First Patient Treated in Mapi Pharma’s Phase II Clinical Trial of GA Depot for Primary Progressive Multiple Sclerosis (PPMS)
Study is being conducted on strength of prior Phase II clinical trial that showed strong efficacy in RRMS patients who switched from Copaxone® to once-monthly GA Depot
NESS ZIONA, Israel, Jan. 30, 2018 (GLOBE NEWSWIRE) — Mapi Pharma Ltd announced today that the first patient has been treated with GA Depot in the company’s Phase II study for primary progressive multiple sclerosis (PPMS). Glatiramer acetate, the active material of Copaxone®, is the most common treatment for RRMS in the US. GA Depot is a long-acting depot formulation injection of glatiramer acetate administered once every four weeks rather than daily or thrice weekly as in the case of Copaxone®. In a recently completed Phase II trial for RRMS, GA Depot showed strong efficacy with 84.6% of the per protocol patient population achieving NEDA (No Evidence of Disease Activity, a composite parameter that combines no relapses, no new MRI lesions and no confirmed disability progressions).
This is a Phase II prospective, multicenter, single arm, open label study designed to assess the safety and efficacy of GA Depot in delaying the accumulation of disability in subjects with PPMS. All patients participating in the study will receive 40 mg intramuscular (IM) injections of GA Depot, administered once every four weeks for 52 weeks. Between 12 to 24 PPMS patients are expected to be enrolled. Patients are currently being recruited at the following medical centers: Tel Aviv Sourasky Medical Center (Ichilov), The Barzilai Medical Center and Assaf Harofeh Medical Center.
“Treating PPMS is of great importance, and finding a safe and effective drug is a major goal. GA Depot has presented early efficacy in RRMS patients and we hope this also benefits PPMS patients, which remains an important medical need,” said Jerry S. Wolinsky, MD, Emeritus Professor in Neurology, McGovern Medical School, UTHealth, The University of Texas Health Science Center at Houston.
“Our goal is that GA Depot will become a first-line treatment for both RRMS and PPMS patients. Mapi is focused on bringing these products to the market and plans to raise additional capital to finance the Phase III trials for these medical indications”, said Ehud Marom, CEO and Chairman of Mapi Pharma Ltd.
About Mapi Pharma Ltd.
Mapi is a development stage pharmaceutical company, engaged in the development of high barrier to entry and high added value life cycle management (“LCM”) products that target large markets and generic drugs that include complex active pharmaceutical ingredients (“APIs”) and formulations. GA Depot is the first in a series of depot long-acting injections in the company’s pipeline. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs and its ability to foster local cooperation and enduring relationships in all of the countries in which it operates. Mapi is headquartered in Israel. It has R&D facilities in Israel and China. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. For more information, please visit: www.mapi-pharma.com
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