Glatiramer Acetate Depot Shows Safety, Effectiveness in Progressive MS, Interim Results Suggest
Individuals with progressive MS demonstrated stable scores on Expanded Disability Status Scale, with no 12-week confirmed disability progression detected.
One-year interim data from a phase 2 study of patients with progressive multiple sclerosis (MS) showed that treatment with glatiramer acetate depot (Mapi Pharma), an intramuscularly administered formulation of the approved treatment given every 4 weeks, was safe and effective based on the low rate of adverse events (AEs) and stable Expanded Disability Status Scale (EDSS) scores.1
Presented at the 2022 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, June 1-4, in National Harbor, Maryland, the interim data included patients with progressive MS, aged 18 to 65 years with rapid disease progression, demonstrated by at least a 1 point increase per year on EDSS in the year prior to screening. The safety assessment, which included AEs, hematology and chemistry tests, was evaluated in 15 individuals while efficacy, as assessed by EDSS, 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), and by MRI was assessed in 13 patients.
At 1 year, treatment with glatiramer acetate depot was shown to be safe, with 88% of the AEs recorded mild in nature. Injection site reactions and asthenia made up the majority of AEs, with no unexpected AEs reported. Two serious AEs, one related and one unrelated to the study drug, were also reported.
Ehud Marom, president and chief executive officer, Mapi Pharma, told NeurologyLive® that, “we have less safety issues than Copaxone. Why? Less injections. Most of the safety issues of Copaxone are site reactions. We have less site reactions [with glatiramer acetate depot] and the dropout is not as big.”
Throughout the interim period, patients showed stable EDSS scores, with no confirmed disability progression detected at 12 weeks. In total, 69.2% of individuals treated with glatiramer acetate depot had no evidence of progression. On MRI analysis, patients had –0.89% change in brain volume from baseline to 1 year and –0.34% change from 6 months to 1 year. Similarly, these patients saw a –2.59% and –1.31% change in cortical volume from the same time points, respectively. Notably, mean 9HPT and T25FW remained stable throughout the analysis.
Glatiramer acetate depot, a long-acting injection version of the approved glatiramer acetate (Copaxone; Teva Pharmaceuticals), is designed to be administered as an intramuscular injection once every 4 weeks. In addition to the phase 2 study, it is currently being evaluated in a large-scale, multinational phase 3 study of patients with relapsing MS. In December 2020, Mapi Pharma announced it had reached 60% of its targeted enrollment goal of 960 individuals.2
In that study, patients receive either 40 mg of glatiramer acetate depot or placebo, once every 4 weeks for a total of 13 doses. Those who complete the initial placebo-controlled period will be given the option to continue into the open-label period for an additional 52 weeks, in which all subjects will receive 40 mg of the study drug once every 4 weeks.
When asked whether a phase 3 study of progressive MS would be on the horizon, Marom first noted the similar active pharmaceutical ingredients between Copaxone and glatiramer acetate make it easy, stating, “We can go directly to phase 3. We are making some adjustments to see what the best dose is by comparing 2 doses. By the end of the year, I’d like to go to the FDA for a pre-IND meeting for a phase 3 trial.” He added, “I believe in about half a year or 1 year we will start the phase 3 trial.”