Glatiramer Acetate Depot Injection for MS Treatment Proves Positive in Front-Line Phase 3 Data

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Mapi Pharma has announced top 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 the rate of relapse annualized (ARR) versus placebo when administered intramuscularly at a dose of 40 mg.1

In total, in the 1016-person trial across more than 100 global sites, those treated with glatiramer acetate depot reported reductions in RAR of 30.1% compared to the placebo group (P = 0.0066). Patients received treatment every 4 weeks, for a total of 13 doses.

The company noted that analysis of the secondary endpoints is still ongoing. Secondary outcomes of the trial include changes in T1 lesion count and T2 lesion count, hyperintense T2 lesion volume change, and improvement in T1 lesion volume change. Additionally, after the 12-month placebo-controlled period, there will be a one-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 provides administration benefits with efficacy. significant. “Monthly administration of GA Depot should offer patients a much more preferable schedule than current GA regimens, a long-standing mainstay in MS treatment, and lead to improved patient satisfaction and medication adherence,” he said.

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

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

At the 2022 annual meeting of the Consortium of Multiple Sclerosis (CMSC), June 1-4, in National Harbor, Maryland, a poster presented the results of a phase 2a trial of patients with progressive MS treated with a depot of glatiramer acetate, administered intramuscularly once every 28 days at a dose of 40 mg. In the one-year snapshot analysis of the trial, the drug was found to be safe and effective, based on the low number of adverse events (AEs) detected and stable expanded state scale scores of disability. In addition, 69.2% of patients showed no signs of progression throughout the study.2.3

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

REFERENCES
1. Mapi Pharma announces the first positive results of the GA Depot phase III trial for relapsing forms of multiple sclerosis (RMS). Press release. MapiPharma. 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 (Extended-Release) Depot Phase 2a Study in Patients with Primary Progressive Multiple Sclerosis: Safety and Efficacy One-Year Interim Snapshot Analysis. Presented at: GFCS Annual Meeting; June 1-4, 2022; National Harbor, MD.
3. Flichter S, Popper L, Kimelman NB, et al. Phase IIa Study of Glatiramer Acetate (Extended Release) in Patients with Primary Progressive Multiple Sclerosis: Overview of Safety and Efficacy (P7-4.001). Neurology. 2022;98(18 Suppl):1329.
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