Tag: study

JCN Newswire

Mitsubishi Shipbuilding and INPEX Complete Conceptual Study for Ammonia Bunkering Vessel

February 2, 2023

TOKYO, Feb 2, 2023 - (JCN Newswire via SEAPRWire.com) - Mitsubishi Shipbuilding Co., Ltd., a Mitsubishi Heavy Industries (MHI) Group company based in Yokohama, has recently completed a conceptual study for an ammonia bunkering vessel capable of supplying ammonia fuel to ships. This study involved joint investigations with INPEX CORPORATION, which boasts abundant achievements and experience in the energy supply chain, in order to respond to increasing demands for ammonia-fueled ships.Image of Ammonia Bunkering VesselSince ammonia does not emit carbon dioxide (CO2) when burned, it is expected to be utilized as a stable source of clean energy in the future, and is getting attention as a fuel that will greatly contribute to the reduction of greenhouse gas emissions in the maritime industry. Mitsubishi Shipbuilding has made use of its ample knowledge of the design and production of multi-purpose liquefied gas carriers, which are capable of transporting ammonia, in furthering conceptual considerations for a highly flexible ammonia bunkering vessel having enough tank capacity, ship maneuverability, and bunkering equipment that ensures compatibility with various ammonia-fueled vessels expected to be served.Based on the knowledge and technical tasks acquired in this study, Mitsubishi Shipbuilding will carry out further technical investigations, and with the cooperation of the maritime-related companies involved and the like, will set its sights on the commercialization of this vessel. Moreover, in order to contribute to customer needs in terms of the whole value chain, Mitsubishi Shipbuilding will continue to put efforts into developing various types of ships.Mitsubishi Shipbuilding is an integral part of MHI Group's Energy Transition strategy. As a maritime system integrator, Mitsubishi Shipbuilding will continue to focus on developing and commercializing not only ammonia bunkering vessels, but alternative fuel vessels and relevant equipment in order to realize a carbon neutral society.About MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world's leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

Lecanemab Receives Priority Review Status in Japan

JCN Newswire

Lecanemab Receives Priority Review Status in Japan

January 30, 2023

TOKYO and CAMBRIDGE, Mass., Jan 30, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal. In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023 and accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) in December 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. *Protofibrils are large Abeta aggregated soluble species of 75-500 Kd. (1),(2)For more information, visit www.eisai.com/news/2023/news202312.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

JCN Newswire

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

January 16, 2023

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

JCN Newswire

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

January 11, 2023

TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.Media Contacts:Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.netBiogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comInvestor Contacts: Eisai Co., Ltd. Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

ACN Newswire

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

January 5, 2023

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 5, 2023 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund. Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases. HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows:-- A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion;-- A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and -- A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC)."After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.Contacts:InvestorsNadia Gaoir@hightidetx.com+86-134-8219-0265MediaKarl Schmiederkarl@messaginglab.com+1-646-515-3392 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

JCN Newswire

MHI Signs MoU with Chile’s Guacolda Energia for Feasibility Study of Ammonia Co-Firing at a Coal-Fired Thermal Power Plant

December 7, 2022

TOKYO, Dec 7, 2022 - (JCN Newswire via SEAPRWire.com) - Mitsubishi Heavy Industries, Ltd. (MHI), on December 6, signed a Memorandum of Understanding (MoU) with Guacolda Energia SpA, an independent power producer (IPP) in the Republic of Chile, to begin a feasibility study for the introduction of ammonia co-firing at a coal-fired thermal power plant operated by the company in the north of the country. The project is being undertaken in response to the global trend toward reducing CO2 emissions.Signing CeremonyThe signing ceremony was held at the Nagasaki Shipyard & Machinery Works in Japan, the base for MHI;s steam power plant business. The executive team from Guacolda was led by Chairman Jorge Rodriguez, with MHI represented by Masahiko Hokano, Head of the Steam Power Maintenance Innovation (SPMI) Business Division.The power plant that will be the site of the study is located in Huasco, Atacama Region, approximately 700 km north of the capital city of Santiago. The plant comprises five power generation units with a total output of 758 megawatts (MW). MHI supplied the boiler, steam turbine, and other core facilities for this plant.Under the feasibility study plan based on the MoU, MHI, with support from its power solutions brand Mitsubishi Power, will determine and conduct a study of supplying the ammonia burners and other boiler facilities and equipment necessary for ammonia co-firing. Phase 1, through 2024, will be a basic study for 30% ammonia co-firing to identify the problems involved. Phase 2, from 2025 to 2026, will be to consider solutions to the problems identified in Phase 1, and compile a detailed plan for demonstration of 30% ammonia co-firing. In the future, Guacolda aims to conduct demonstration testing at the plant and increase the co-firing rate.Chile has set a target for carbon neutrality by 2050 and plans to increasingly incorporate non-conventional renewable energy sources into the Chilean electricity matrix. As a country with abundant renewable energy resources, Chile is considered to have high potential as a producer of green ammonia, and Guacolda is looking to ammonia co-firing as a means of cutting CO2 emissions and reducing its environmental load in order to maintain operations at its power plant. MHI's position as the supplier of the core facilities of this power plant, and a leader in ammonia co-firing technologies, led to the conclusion of this MoU.Commenting on the signing of the MoU, Guacolda Chairman Jorge Rodriguez said: "A rational policy to reduce greenhouse gases should consider a gradual withdrawal from the use of fossil fuels, combining them with more climate-friendly energies such as green hydrogen, green ammonia and long-term storage technologies, in the most economical way possible but always safeguard the safety of the electrical system as a whole."Masahiko Hokano, Head of the SPMI Business Division at MHI said: "We are very honored to be able to proceed with this feasibility study on ammonia co-firing in Chile, which is highly proactive in decarbonization efforts and has great expectations from the world in terms of renewable energy and clean fuel derived from it. By combining MHI's innovative ammonia co-firing technology with Guacolda's deep technical knowledge and power plant management know-how, we are confident that we can contribute to the further acceleration of decarbonization in Guacolda, and consequently in Chile."Going forward, building on the conclusion of this MoU, MHI will work offer the solutions for decarbonization and improved performance needed by IPPs and the entire power generation industry around the world, and will make a concerted effort to successfully complete this feasibility study, contributing to the stable supply of energy and the reducing of environmental loads.About MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world's leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

JCN Newswire

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

November 30, 2022

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, in San Francisco, California and virtually.Figure 1: CDR-SB as Primary endpoint change (18 months)Summary of Presentations in the Scientific Session featuring Lecanemab at CTADDesign of Clarity AD StudyEisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia. The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup (MCI due to AD or mild AD), presence or absence of concomitant approved AD symptomatic medication at baseline (e.g., acetylcholinesterase inhibitors, memantine, or both), ApoE4 status and geographical region. Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants. As a result of Eisai's recruitment strategy of diversity in the Clarity AD study, 4.5% and 22.5% of the randomized participants in the U.S. were Black and Hispanic, respectively.The primary endpoint was change from baseline at 18 months in the CDR-SB1 (Clinical Dementia Rating Sum of Boxes), the global cognitive and functional scale, and key secondary endpoints were the change from baseline at 18 months in amyloid Positron Emission Tomography (PET) using Centiloids, AD Assessment Scale - Cognitive Subscale 14 (ADAS-Cog142), AD Composite Score (ADCOMS3) and AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL4). In addition, longitudinal changes in brain tau pathology as measured by tau PET (n=257) and cerebrospinal fluid (CSF) biomarkers of AD pathology (n=281) were evaluated in optional sub-studies.Efficacy Results of Clarity ADMean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45 (95% Confidence Interval (CI): -0.67, -0.23; P=0.00005), representing a 27% slowing of decline. Starting as early as six months (difference: -0.17 [95% CI: -0.29, -0.05]; PAll key secondary endpoints also showed highly statistically significant results compared with placebo (PFor more information, visit www.eisai.com/news/2022/pdf/enews202285pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

JCN Newswire

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

November 30, 2022

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals. For the details of the paper, please refer to: www.nejm.org/doi/full/10.1056/NEJMoa2212948.The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2022/pdf/enews202284pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

AJG Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

ACN Newswire

AJG Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

November 17, 2022

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 17, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology. (https://journals.lww.com/ajg/Fulltext/2022/11000/A_Randomized,_Dose_Finding,_Proof_of_Concept_Study.22.aspx)This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

American Journal of Gastroenterology Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

November 16, 2022

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 16, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology.This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872American Journal of Gastroenterologyhttps://tinyurl.com/mr3wyhu6 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

JCN Newswire

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

November 2, 2022

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared. In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: "Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product." Based on the safety data in 702 patients and efficacy data in 495 patients submitted to the MHLW as the results of analyses of this all-case study, the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition. Eisai will continually strive to promote the proper use of Inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.For more information, visit www.eisai.com/news/2022/news202275.html.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

JCN Newswire

Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

November 2, 2022

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged. The indication of "suppression of progression of dementia symptoms in DLB" was approved in September 2014, primarily based on a Phase II study (Study 431) and Phase III study (Study 341) conducted by Eisai on people living with DLB in Japan. In accordance with the condition for the approval of this indication, "a clinical trial to verify the efficacy and safety of the drug in patients with DLB should be conducted and the results of the trials and analyses should be submitted promptly after completion," Eisai conducted a post-marketing clinical study (Study 419) to evaluate the efficacy and safety of the drug in patients with DLB. The results of Study 419 did not show a statistically significant difference between the placebo group and the Aricept group in the primary endpoint of global function (CIBIC-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of Study 419, stated that "at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients. On the other hand, treatment with this drug showed a trend toward improvement in cognitive function (MMSE***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. Since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed."Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2).The condition of the approval was lifted as of the date of receipt of the reexamination results. Along with this prompt application for a partial change to label regarding dosage and administration for the DLB indication, Eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families. For more information, visit www.eisai.com/news/2022/news202274.html. Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

Sinomab Announces IND Application of SN1011 for the Treatment of Neuromyelitis Optica Spectrum Disorder Approved by NMPA

August 24, 2022

HONG KONG, Aug 24, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous ("SLE"), pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder("NMOSD") and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company's new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of Company's main candidate products, covering indications in the field of autoimmune diseases, have entered clinical stage gradually. Among which, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates moving forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoting to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases. About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Eisai to Present at The Alzheimer’s Association International Conference (AAIC) 2022

JCN Newswire

Eisai to Present at The Alzheimer’s Association International Conference (AAIC) 2022

July 26, 2022

TOKYO, Jul 26, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co. Ltd announced today that the company will present research from its Alzheimer's disease (AD) pipeline, including new data for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, at the Alzheimer's Association International Conference (AAIC) to be held in San Diego, CA and virtually from July 31 to August 4, 2022. Eisai will present data and research in three oral and 18 poster presentations at the meeting.On July 5, 2022 (U.S), Eisai announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and was granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.Key Eisai AAIC Presentations- Effect of Genotype on ARIA-E Incidence by Lecanemab: Results from a modeling simulation to evaluate the effect of APOE4 genotype on ARIA-E incidence from study 201 Core and comparison to the observed incidence in the open-label extension among those newly treatedwith lecanemab. (Virtual Developing Topics #69402) - Lecanemab Subcutaneous Dosing:Results from a study in healthy subjects to evaluate the absolute bioavailability, pharmacokinetics, safety, and immunogenicity of lecanemab following a single fixed 700 mg subcutaneous dose. (Poster/Abstract #69438)Modeling and simulation analysis aimed at showing the equivalence of fixed weekly subcutaneous dose of lecanemab to body weight-based 10mg/kg biweekly intravenous dose. (Poster/Abstract #69429)- Ethnic and Racial Diversity in Eisai Clinical Trials: An evaluation of US enrollment across lecanemab (Study 201 and Clarity AD) and elenbecestat MissionAD studies in early AD to assess racial and ethnic groups and the impact of eligibility criteria in the United States. (Poster/Abstract # 69198)- Beta-Amyloid Assays Predict Brain beta-Amyloid Pathology: Data from the Eisai and Sysmex collaboration reporting on the fully automated plasma Abeta40 and Abeta42 immunoassays and their performance for predicting brain Aβ pathology defined by amyloid PET. (Poster/Abstract # 68727) - Comprehensive CSF Tau Profiling from Dominantly Inherited Alzheimer Network (DIAN): An oral presentation that shares results from a study in patients enrolled in Washington University School of Medicine's DIAN-observational cohort that used Eisai's anti-microtubule binding region (MTBR) antibody, E2814, to profile MTBR-tau and then assessed timing to MTBR-tau changes in CSF and correlation to clinical, cognitive, and biomarker changes. (Oral Presentation # 65313)"The lecanemab data Eisai will present at AAIC 2022 continues to build the body of knowledge about our investigational anti-amyloid beta protofibril antibody as we work toward the Phase 3 confirmatory Clarity AD readout this fall," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Alzheimer's Disease and Brain Health, Eisai Inc. "Additional research presented will highlight Eisai's efforts to improve ethnic and racial diversity in our early Alzheimer's disease clinical trials in the United States so that study populations mirror the U.S. Medicare population, as well as research from our collaboration with Sysmex on potential biomarkers that may contribute to early diagnosis of Alzheimer's disease."For more information, visit https://www.eisai.com/news/2022/pdf/enews202257pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

TrialWire Technology Platform Rolls Out World First SMS/Text Patient Contact System Across all Studies Globally

ACN Newswire

TrialWire Technology Platform Rolls Out World First SMS/Text Patient Contact System Across all Studies Globally

July 20, 2022

ADELAIDE, AUS, Jul 20, 2022 - (ACN Newswire via SEAPRWire.com) - TrialWire(TM) Technology Platform, the most secure and rapid digital patient recruitment Platform for trial rescue, today announced the rollout of the proprietary SMS/Text patient contact system across all studies globally.The SMS/Text patient contact system is a world first in speed, security, and compliance for study coordinators contacting patients to discuss their study application and site bookings.It is primarily designed to speed up the contact process which is typically delayed using phone or email. Up to 50% of patients can be lost due to contact failure because they often don't answer an unknown number call from a site. In addition, study coordinators often can't afford the time to call more than 3-4 times in the hope of connecting with the patient.TrialWire has found from patient responses that 92% want to be contacted by SMS/Text so this was a driving force behind the development and rollout of the service. This includes studies for older people.The SMS/Text system can support all languages and keeps a record in the study coordinator's Dashboard of all conversations.Most study coordinators are using the contact system to arrange then confirm times for screening calls, or site screening visits.TrialWire recruitment can start in under 24-hours because the Platform doesn't require approvals. The TrialWire Technology Platform includes:- Dedicated secure dashboards for each Study Coordinator where they can review patient details and medical information- Multiple dashboards per site so all Study Coordinators can see real-time progress- Dashboards for sponsors and CROs where they can see de-identified referral status information- Secure SMS system inside their dashboards for instant communications with the patient - book calls and screening visits- Automated AI-Match and algorithm-driven "find and screen" patients process- Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site- Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled - across all sites on a study- HIPAA compliance and all patient privacy security - Built on the Salesforce Health Cloud- Unlimited number of sites globally- Available in all languages With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals - 10% of sites don't enroll any patients - TrialWire offers peace of mind for sponsors and their CROs.TrialWire is ideal for sponsors and CROs wanting to avoid extended recruitment delays.Request more information here - starts in 24 hours https://trial-wire.com/contact/Learn more here https://www.trial-wire.com/About TrialWire www.trial-wire.comTrialWire is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire, which is solving the most serious problem in the drug development sector, has a recent valuation of USD$27m. Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.The TrialWire Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study - site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.Key to the TrialWire success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire does NOT keep patient details once a study is completed - no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)