Israeli biomed firm Mapi Pharma Ltd., which is a development stage pharmaceutical company, announced that the first patient was treated in the company’s Phase IIa study of a new drug for the treatment of relapsing remitting multiple sclerosis (RRMS), GA Depot.
Glatiramer Acetate is the active ingredient in Copaxone, the most common treatment for RRMS. GA Depot is a long-acting depot formulation injection of Glatiramer Acetate given once a month rather than daily or thrice weekly as in the case of Copaxone®.
Professor Ariel Miller, M.D., Ph.D., Head, Multiple Sclerosis & Brain Research Center, Carmel Medical Center and the coordinating principle investigator of the Phase IIa study, said, “We are very enthusiastic about this trial. GA Depot has the potential to significantly improve the mode of treatment of patients with MS by dramatically reducing the number of injections, increasing patient compliance, and providing a therapeutic benefit.
All patients participating in the Phase IIa, open-label, single-arm study will receive 80 mg intramuscularly (into a muscle) injections of GA Depot, once every 4 weeks, rather than daily or thrice-weekly subcutaneously (under the skin) injections as is the case with Copaxone. The on-going, multi-center clinical trial is currently recruiting 20 patients, who have previously been treated with Copaxone for at least 12 months. Clinical sites include: Carmel Medical Center, Sheba Medical Center, Tel Aviv Sourasky Medical Center (Ichilov) and Barzilai Medical Center. The study will assess safety, tolerability and efficacy of GA Depot in the patients. All participants will be treated and followed for one year.
“We are confident that the future of Glatiramer Acetate as a cornerstone treatment for MS is solid and will be strengthened by the monthly injection Mapi is developing. The company has plans to start the Phase III pivotal clinical trial in 2015 and intends to file for registration of the new product in 2018, ” said Ehud Marom, chairman and CEO of Mapi Pharma. “Industry feedback regarding Mapi’s current and pipeline plans has been extremely positive. We look forward to continuing, as well as establishing, new, high level discussions with potential partners both in big pharma and in the investment community.”
Mapi is headquartered in Israel and has R&D facilities in Israel and China. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations.