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MS Treatment Glatiramer Acetate Depot Injection Proves Positive in Topline Phase 3 Data

The Mapi Pharma treatment, administered intramuscularly at 40 mg, reduced annualized relapse rates among a population of patients with relapsing multiple sclerosis. Secondary outcomes are still being analyzed.

Mapi Pharma has announced the topline results from its phase 3 study (NCT04121221) of its glatiramer acetate depot (GA Depot) as a treatment for relapsing multiple sclerosis (MS), with the therapy significantly reducing annualized relapse rate (ARR) compared with placebo when administered intramuscularly in a dose of 40 mg.1

All told, in the trial of 1016 individuals across more than 100 global sites, those treated with glatiramer acetate depot reported reductions in ARR of 30.1% compared with the placebo group (P = .0066). Patients received treatment every 4 weeks, for a total of 13 doses.

The company noted that the analysis of secondary end points is still ongoing. Secondary outcomes in the trial include changes number of T1 lesions and number of T2 lesions, hyperintense T2-lesion volume change, and enhancing T1-lesion volume change. Additionally, after the 12-month placebo-controlled period, there will be a 1-year open-label extension.

The study’s principal investigator, Aaron Miller, MD, medical director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, said in a statement that the therapy offers administration advantages with significant efficacy. “The monthly administration of GA Depot should offer patients a much more preferable schedule than current regimens of GA, a long-standing pillar in the treatment of MS, and lead to improved patient satisfaction and medication adherence,” he said.

“We are pleased with the topline results of this study that show the potential of GA Depot 40 mg to offer patients an effectivetreatment option using a more convenient dosing regimen which may potentiallyimprove compliance and adherence,” Ehud Marom, CEO and chairman, Mapi Pharma, said in a statement.1 “We believe the positive results set us on a path to commercialize GA Depot and we will work with our partner Viatris to make this potentially valuable new treatment option available to patients with RMS as early as possible. We look forward to providing the other secondary endpoints and overall safety and tolerability of the drug in the near future.”

Mapi has also initiated an open-label, phase 2 trial (NCT03362294) to continue examining the therapy in the primary progressive MS population. The company anticipates enrolling 30 adults, ages 18 to 65 years, at sites in Israel and Moldova, who will receive glatiramer acetate depot at a monthly dose of 25 mg or 40 mg for an estimated 3 years.

At the 2022 Consortium of Multiple Sclerosis (CMSC) Annual Meeting, June 1-4, in National Harbor, Maryland, a poster featured phase 2a results from a trial of patients with progressive MS treated with glatiramer acetate depot, administered intramuscularly once every 28 days at a 40-mg dose. In the 1-year snapshot analysis of the trial, the drug was shown to be safe and effective, based on the low number of adverse events (AEs) detected and the stable Expanded Disability Status Scale scores. Additionally, 69.2% of patients demonstrated no evidence of progression throughout the study.2,3

To learn more about the differences, as well as advantages, of this new formulation of glatiramer acetate compared with Copaxone (Teva Pharmaceuticals), NeurologyLive® sat down with Marom, who provided insight on the positive safety findings observed to date, and how this drug might compare with others in the field. Watch him discuss below [WATCH TIME: 4 minutes].

REFERENCES
1. Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS). News release. Mapi Pharma. September 21, 2022. Accessed September 21, 2022. https://mapi-pharma.com/mapi-pharma-announces-positive-top-line-results-from-ga-depot-phase-iii-trial-for-relapsing-forms-of-multiple-sclerosis-rms/
2. Fletcher S, Kimelman NB, Danon U, et al. Glatiramer acetate depot (extended release) phase 2a study in patients with primary progressive multiple sclerosis: safety and efficacy 1 year interim snapshot analysis. Presented at: CMSC Annual Meeting; June 1-4, 2022; National Harbor, MD.
3. Flechter S, Popper L, Kimelman NB, et al. Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy Snapshot (P7-4.001). Neurology. 2022;98(18 Suppl):1329.