A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS).

The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55 years old, who have been diagnosed with relapsing MS.

Two clinical sites are currently recruiting participants: the North Central Neurology Associates in Cullman, Alabama, and the Mountain View Clinical Research in Denver, Colorado. Find more information here.

Participants will be randomly assigned to receive treatment with either 40 mg GA Depot or a matching placebo, administrated via intramuscular injection, once every four weeks for a total treatment period of 52 weeks.

All patients who complete the treatment will have the opportunity to roll over to an open-label treatment period, in which they will receive DA Depot for an additional 52 weeks.

This trial will allow researchers to evaluate the ability of monthly injections of GA Depot to prevent MS relapse episodes, and disease progression. The primary goal of the trial is to evaluate changes in annualized relapse rate during the 52 weeks of treatment. Secondary outcome measures include analysis of brain magnetic resonance imaging (MRI).

“Treating relapsing MS is of great importance and there is a significant unmet need for a product such as a long acting glatiramer acetate, which has disease modifying potential, and appears safe and well tolerated. The ability to achieve reliable dosing by means of a once monthly dose schedule is expected to ensure adherence to the treatment,” Aaron Miller, MD, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, and principal investigator of the trial, said in a news release.

GA Depot has been developed as a once-a-month alternative to relapsing MS approved therapy Copaxone (glatiramer acetate injection, by Teva Pharmaceuticals). Despite the demonstrated capacity of Copaxone to act as a disease-modifying MS therapy, it requires frequent dosing, either daily or three times a week.

“Our goal is to develop and launch the best drug for MS, and we believe that GA Depot has a compelling profile, combining the safety of Copaxone with better efficacy and the potential for improved compliance,” Ehud Marom, CEO and chairman of Mapi Pharma, said. “We believe that a product with these attributes will convince doctors, payers and MS patients to select it as a first choice treatment for relapsing MS.”

Results from an ongoing Phase 2 trial (NCT02212886) revealed that 84.6% of patients with relapsing-remitting MS (RRMS) who were treated with GA Depot achieved NEDA-3 status — no evidence of disease activity (no relapses, no new MRI lesions, and no confirmed disability progression) — within the first year of therapy. After three years, this status was achieved by 90% of the patients.

“We hope the efficacy that was demonstrated in the Phase 2 study can be confirmed in the ongoing Phase 3,” said Miller, who is also professor and vice chair for education of the neurology department at Icahn School of Medicine at Mount Sinai, in New York.

GA Depot is also currently being tested in a Phase 2 trial (NCT03362294) as a treatment for patients with primary progressive MS (PPMS). The trial, which is currently recruiting, plans to enroll 24 patients across clinical sites in Israel. More information about this trial is available here.

In 2018, Mapi Pharma entered into an agreement with Mylan, under which Mylan has an exclusive license to commercialize the GA Depot product.

“We’re pleased to partner with Mapi on this important product for MS patients, and look forward to advancing to the Phase 3 clinical trials,” said Rajiv Malik, Mylan‘s president. “We continue to be encouraged by the success of the scientific program to date and remain committed to bring GA Depot to market at the earliest opportunity.”