Interim analysis of Phase IIa study of GA Depot in PPMS will be presented
NESS ZIONA, Israel – May 31, 2022 – Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable solutions mainly for neurological indications, announced today that it will present a poster featuring novel clinical data on the treatment of Primary Progressive Multiple Sclerosis (PPMS) with GA Depot at the forthcoming Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2022 to take place in-person only at the Gaylord National Resort & Convention Center, 201 Waterfront Street, National Harbor, Maryland, June 1-4, 2022.
GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®/Glatopa®). PPMS is characterized by worsening neurologic function from the onset of symptoms, without early relapses or remissions. GA Depot consists of extended-release microspheres containing GA, administered intramuscularly (IM) once every 28 days.
The poster will highlight interim data from the Phase IIa study (NCT03362294) evaluating the safety and efficacy of GA Depot treatment (for up to 52 weeks) in PPMS. This analysis includes data on all subjects who were enrolled and completed one year on study or withdrew before.
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said, “We are very pleased to have the opportunity to share the 1-year snapshot data on our GA Depot from the Phase IIa study for PPMS at this year’s CMSC conference. The data suggest that GA Depot is a safe and effective treatment for patients with PPMS, based on the stable EDSS for both men and women, no 12 weeks Confirmed Disability Progression (CDP) that contributed to No Evidence of Progression (NEP) being observed in 69.2% of patients. These results are very encouraging and we intend to evaluate GA Depot in a controlled global double blind Phase III study. This will begin following the completion of our ongoing final stage of a pivotal Phase III study in relapsing forms of MS (RMS), which is expected to read-out in Q3 2022 and which is partnered with Viatris (NASDAQ: VTRS).”
The company welcomes attendees to meet with management at CMSC to learn more about our programs and discuss Mapi’s future pipeline for RRMS, PPMS and an anti-BMP drug for remyelination in MS as well as partnering options for GA Depot’s PPMS indication.
PPMS Title: Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy 1 Year Interim Snapshot Analysis
Date / time: Authors stand by poster Thursday, June 2nd at 6-7pm EDT
Poster # ID# 8374
Questions may be submitted by contacting Mapi directly or at the poster during the time above. Copies of the poster will be available on the Mapi Pharma website, following the CMSC conference, here: https://mapi-pharma.com/news-events/events-presentations/
About Mapi Pharma
Mapi is a clinical stage pharmaceutical company, engaged in marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in a specific markets as well as 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. The product is a LCM version of Copaxone®, which requires injections daily or every other day. 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. 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
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