NESS ZIONA, Israel, April 16, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable treatments, will present efficacy data from GA Depot clinical studies in patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) at the American Academy of Neurology (AAN) Annual Meeting 2026, to take place April 18-22, 2026, in Chicago IL.
Mapi’s Glatiramer Acetate Depot (GA Depot) is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®) for treating multiple sclerosis (MS), a chronic inflammatory, demyelinating disease characterized by neurological disability accumulation over time. GA Depot was clinically evaluated for RMS which is characterized by inflammatory attacks (relapses) on the central nervous system, causing new or worsening neurological symptoms followed by partial or full recovery and PPMS which is characterized by continued worsening neurologic function from the onset of symptoms, without early relapses or remissions. EDSS (Expanded Disability Status Scale) assessments were collected from two prospective GA Depot clinical studies: an up to three year, open-label, Phase IIa study in PPMS patients (n=30), and a one-year, double-blind, placebo-controlled, pivotal Phase III study in RMS patients (n=1,016 of which n=508 were in the active arm). GA Depot is administered intramuscularly (IM) once every 28 days for both indications at different dosages.
In the above studies in PPMS and RMS, GA Depot showed EDSS stabilization, irrespective of baseline EDSS scores. These EDSS findings suggest GA Depot’s potential in slowing disability progression, reinforcing its role in MS management.
GA Depot is in a final review process in Germany for the RMS indication and is planned to start a global Phase III study for PPMS. Mapi received the Israeli Ministry of Health’s GMP (Good Manufacturing Practice) approval, enabling commercial launch in RMS in 2027 in Germany and in EU countries and initiation of marketing early 2028.
Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We are very excited to share these positive results for GA Depot in the treatment of MS, where there are significant unmet medical needs. The data we are presenting this week at AAN demonstrate that GA Depot can significantly impact disease progression and we believe that this product, once approved, has the potential to transform the treatment landscape for MS. We look forward to further evaluating GA Depot in the clinic in the PPMS indication and are currently seeking a co-marketing partner for GA Depot for the RMS indication in the EU.”
The GA Depot data will be featured in a poster GA Depot (long-acting IM glatiramer acetate) and its impact on EDSS in Relapsing forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS) on Tuesday, April 21, 8:00 AM - 9:00 AM CDT (Poster Neighborhood 19 P7: Multiple Sclerosis: Clinical Trials 1, McCormick Place West, Hall F).
Company management will be available for one-on-one meetings during the conference to discuss potential joint development collaborations. Interested parties should contact Mapi directly.
About Mapi Pharma
Mapi Pharma (Mapi) 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. Mapi is developing depot long-acting injections for the anti-psychotic Cariprazine and for the GLP-1’s, Semaglutide and Tirzepatide for diabetes and weight management as well as a generic AB rated version for Naltrexone (Vivitrol®). The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi is built on strong chemical and pharmaceutical R&D and clinical development capabilities and a deep understanding of the global market and of regulatory needs. Mapi is a global company with a dedicated long-acting depot R&D laboratory and aseptic depot manufacturing and a Fill & Finish for injectable Finished Dosage Forms. Mapi has strong IP positions, numerous granted patent applications for APIs and mainly formulations. 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
Brian Ritchie
Managing Director
LifeSci Advisors, LLC
britchie@lifesciadvisors.com
