NESS ZIONA, Israel – March 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 two posters featuring clinical data on GA Depot will be presented at the forthcoming American Academy of Neurology annual meeting, to take place in-person in Seattle, WA, April 2 to 7, and virtually April 24 to 26. GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®/Glatopa®).
Ehud Marom, Chairman and Chief Executive Officer of Mapi, said, “We are very pleased to have the opportunity to share these data on our long-acting GA Depot presented at this year’s American Academy of Neurology meeting. GA Depot is now in the final stages of a Phase-3 study in relapsing forms of MS (RMS) which is expected to read-out in Q3-2022 and is partnered with Viatris (NASDAQ: VTRS). At AAN, we will be presenting 5 year follow up data from our successful Phase IIa study in RRMS. We are also excited by the results we see in the ongoing Phase II study for GA Depot in primary progressive MS (PPMS) patients, to be presented at the meeting as we plan to initiate a Phase-3 for PPMS at the end of 2022.”
The company welcomes attendees to meet with us at AAN to learn more about our programs and discuss Mapi’s future pipeline for RRMS, PPMS, SPMS and an anti-BMP drug for remyelination in MS.
RRMS
Title: Five Years Analysis of anti-Glatiramer Acetate (GA) Antibodies in Patients with Relapsing Remitting Multiple Sclerosis Treated with GA Depot
Session: Session P5: MS Clinical Trials and Therapeutics 1
Date / time: Sunday April 3 11:45 am-12:45 pm PT
Poster # P5.010
GA Depot activity was evaluated in a long-term Phase IIa study in relapsing remitting MS (RRMS) patients. As part of the clinical and safety assessment, serum samples from patients were collected and analyzed for antibodies to glatiramer acetate. Results of the 5 year analysis will be presented.
PPMS
Title: Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy Snapshot
Session: Session P7: MS Clinical Trials and Therapeutics 3
Date / time: Monday, April 4 08:00 am-09:00 am PT
Poster # P7.001
This poster contains results from the ongoing Phase IIa study of GA Depot in PPMS. Safety and efficacy snapshot results on the 12 out of 16 primary progressive MS (PPMS) subjects enrolled out of the 24 planned will be presented.
Questions may be submitted by contacting Mapi directly or at the poster during the time above. Copies of the posters will be available on the Mapi Pharma website, following the AAN meeting, 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®) 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 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
Contacts:
Alex Mogle
Vice President, Corporate Development
Mapi Pharma
+972 52 6080297
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6979
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