GA Depot is a Potential Long Acting Injection Solution for Multiple Sclerosis Patients
Positive Results from Phase III GA Depot Study in Relapsing MS to be Reviewed
Webinar on Wednesday, October 19, 2022 @ 10:30 AM ET
NESS ZIONA, Israel, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, announced today it will host a key opinion leader (KOL) webinar on Glatiramer Acetate (GA) Depot, a potential long-acting injection solution for multiple sclerosis (MS) patients, on Wednesday, October 19, 2022 at 10:30 AM Eastern Time.
The webinar will feature KOL neurologists Aaron Miller, MD, from Mount Sinai, and Carlo Tornatore, MD, from Georgetown University Medical Center, who will discuss Mapi Pharma’s successful Phase III GA Depot clinical results and the contribution a monthly GA Depot will potentially have on improving standard of care to MS patients. Additionally, the KOLs will provide a comprehensive overview on the treatment landscape for Relapsing Forms of MS (RMS) and the unmet medical need for a long-acting monthly injection as compared to the approved daily or 3x/week GA injection, commercially available as Copaxone®, and its generic versions. Ehud Marom, Mapi Pharma’s Chairman and CEO will present the company’s promising long-acting Depot injectable pipeline with a focus on Semaglutide (SG) Depot for treating diabetes, weight control and potentially Parkinson’s Disease and other Depot products which will be registered via the FDA 505(b)(2) regulatory pathway or as ANDA that address billions of dollars markets.
A live Q&A session will follow the formal presentations. To register for the event, please click here.
Positive top-line results from the GA Depot Phase III study were announced by Mapi Pharma in September 2022. The study is designed to assess the efficacy, safety and tolerability of a once monthly GA Depot 40 mg compared to placebo in relapsing forms of multiple sclerosis (RMS) patients. The primary endpoint was met, showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066). Mapi Pharma and its partner Viatris plan to work with regulatory authorities in the major markets to determine next steps.
Aaron Miller, MD, is the Medical Director of the Corinne Dickinson Center for Multiple Sclerosis and a Professor of Neurology at the Icahn School of Medicine at Mount Sinai. He also serves as Vice-Chair of Education in the Department of Neurology. For 23 years prior to becoming Medical Director, he headed the Division of Neurology at Maimonides Medical Center in Brooklyn, New York, where he also served as director of the Multiple Sclerosis Care Center. Dr. Miller served as Chief Medical Officer and Chairman of the Medical Advisory Board of the National Multiple Sclerosis Society (NMSS) from October 2009-2022 and is the immediate past president of the National Medical Advisory Board. He also served as the Chairman of the Clinical Advisory Committee of New York City Chapter of the NMSS from 1991-2004. He formerly served as the Chairman of the Professional Education Committee of the NMSS and is a past president of the Consortium on MS Centers. He was a member of the National Board of the NMSS from 2022-2017. Dr. Miller received the Hope Award from the National MS Society ion 2021.
Dr. Miller was the first chairman of the multiple sclerosis section of the American Academy for Neurology and has participated in numerous clinical trials of new treatments for multiple sclerosis. Dr. Miller is also very active with the American Academy of Neurology for which he served as Editor of Continuum Audio from 2012-2021. He was secretary of the AAN Board (2013-2017) and also a member of the Board from 2009-2013. From 1997-2003, he served as Co-Chairman of the Education Committee and Chairman of the Annual Meeting Subcommittee.
Carlo Tornatore, MD is Chairman, and Neurologist-in-Chief of the Department of Neurology and Executive Director of the Multiple Sclerosis Patient-Centered Specialty Practice for Medstar at Georgetown University Hospital. He is also Professor and Chairman of the Department of Neurology at Georgetown University Medical Center and Physician Executive Director for Neurology at Medstar Health.
Dr. Tornatore earned his Master’s degree in Physiology at Georgetown University and his medical degree at Georgetown University Medical School. He completed his internship at Providence Hospital and his Residency in neurology at Georgetown University Hospital. His fellowship was completed at the National Institute for Neurologic Disorders and Stroke at the National Institutes of Health (NIH) in the Laboratory of Molecular Medicine and Neuroscience in Bethesda, MD.
Dr. Tornatore is a member of the American Academy of Neurology and American Society for Neural Transplantation. His research interests include multiple sclerosis treatment, neuroimmunology, neuro-AIDS, and infectious diseases of the central nervous system, for which he has published a wide variety of articles and book chapters. In addition, he is a reviewer for several journals, including Annals of Neurology, Neurology and Medical Virology.
About the Phase III Study
The multinational Phase III Study was designed to examine the safety, efficacy and tolerability of a 40 mg GA intramuscular injection administered once every four weeks compared to placebo in a randomized double-blind placebo-controlled design in patients with RMS. The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase. A total of 1,016 subjects were randomized into two groups, receiving either 40 mg of GA Depot or placebo once every 4 weeks for a total of 13 doses.
About GA Depot
GA Depot is a long-acting injection version of the approved subcutaneous GA injection, commercially available as Copaxone®, designed to be administered as an intramuscular injection once every four weeks. GA Depot is intended to be used for treatment of RMS.
About Mapi Pharma
Mapi Pharma is a clinical stage pharmaceutical company engaged in development of high barrier-to-entry and high added-value life cycle management (“LCM”) products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients (“APIs”) and formulations. The GA Depot injection, administered once every four weeks, is the first in a series of depot long-acting injections in the company’s pipeline for the treatment of MS. Mapi Pharma partnered with Viatris (NASDAQ: VTRS) for GA Depot in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of multiple sclerosis. Mapi’s portfolio also includes a leading development of Depot GLP-1 for diabetes, weight control, Parkinson’s disease and potentially Alzheimer’s disease with innovative IP. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs. Mapi is headquartered in Israel, with R&D facilities in Israel and China, an API production facility in the Neot-Hovav Eco Industrial Park and an aseptic manufacturing and a Fill & Finish facility for injectable Finished Dosage Forms in Jerusalem. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations and is manufacturing and marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific markets. Mapi Pharma was founded by Ehud Marom who serves as Chairman & CEO of Mapi Pharma and Stem Cell Medicine. For more information, please visit: www.mapi-pharma.com
Contacts:
Alex Mogle
Vice President, Corporate Development
Mapi Pharma
+972 52 6080297
alex@mapi-pharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6979
bob@LifeSciAdvisors.com
