Israeli drug development company Mapi Pharma Ltd., has reported positive Phase II results of its lead product Glatiramer Acetate (GA/Copaxone) Depot for the treatment of relapsing remitting multiple sclerosis (RRMS). The treatment is designed to be taken just once monthly in contrast to Teva's Copaxone, which must be administered twice weekly.
25 patients previously treated for at least one year with Copaxone were enrolled in the trial. GA Depot was injected every 4 weeks and had a linear release profile over 30 days. The study achieved the primary endpoint for safety and tolerability. The data suggests a good safety and tolerability profile for the 40mg dose, which was superior to the 80mg dose.
Adverse events include injection site reactions, which were mainly mild and transient. The main injection site reactions reported were pain, induration, swelling and erythema.
Prof. Aaron Miller, Professor of Neurology, Icahn School of Medicine at Mount Sinai Hospital, NY, and the Coordinating PI for Mapi's Phase III trial with GA Depot, said, “GA Depot offers a monthly injection versus the daily or thrice-weekly injections of glatiramer acetate sold in the market today. If the Phase III results replicate those of Phase II, GA Depot is expected to significantly improve the mode of treatment for patients with MS by significantly reducing the number of injections, easing the treatment burden and increasing patient compliance.”
Mapi chairman and CEO Ehud Marom said, “Following the capital raise we concluded in Q3 2017, we will be initiating the Phase III trial in 2018 and are currently looking for the best partner to commercialize our drug. GA Depot, if approved, will provide patients with an improved quality of treatment experience at a reduced burden, and has the potential to become a leading therapy for MS.”
Based in Ness Ziona, Mapi Pharma develops high barrier-to-entry, high added-value lifecycle management pharmaceuticals and complex active pharmaceutical ingredients (API) and formulations. The company had planned a Nasdaq IPO in 2014 but could not achieve the valuation it sought, and consequently it remains privately owned. In August Mapi Pharma raised $10 million from Marius Nacht and Dr. Yair Schindel's aMoon fund.
Published by Globes [online], Israel business news - www.globes-online.com - on November 1, 2017
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