Mapi Pharma treats first patient in Phase IIa trial of GA Depot to treat RRMS

18th December 2014 (Last Updated December 18th, 2014 18:30)

Israel-based Mapi Pharma has treated the first patient in its Phase IIa trial of GA Depot being developed to treat relapsing remitting multiple sclerosis (RRMS).

Israel-based Mapi Pharma has treated the first patient in its Phase IIa trial of GA Depot being developed to treat relapsing remitting multiple sclerosis (RRMS).

GA Depot is a long-acting depot formulation injection of Glatiramer Acetate which is given once a month rather than daily or thrice weekly as in the case of Copaxone, the most common treatment for RRMS.

The company said that Glatiramer Acetate is the active ingredient in Copaxone.

"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."

GA Depot is intended to give the same therapeutic benefits as Copaxone and other current treatments in the market.

Medical Center head of Multiple Sclerosis & Brain Research Center and the coordinating principle investigator of the Phase IIa trial professor Ariel Miller said: "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."

During the open-label, single-arm Phase IIa trial, patients will be given 80mg intramuscularly (into a muscle) injections of GA Depot, once every four weeks, rather than daily or thrice-weekly subcutaneously (under the skin) injections as is the case with Copaxone.

The on-going, multi-centre clinical trial is enrolling 20 patients, who have previously been treated with Copaxone for at least 12 months.

The clinical sites include Carmel Medical Center, Sheba Medical Center, Tel Aviv Sourasky Medical Center (Ichilov) and Barzilai Medical Center.

The trial is designed to evaluate the safety, tolerability and efficacy of GA Depot in these patients.

According to the company, all participants will be treated and followed for one year.

Mapi Pharma chairman and CEO Ehud Marom said: "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.

"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."