Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, announced today positive top-line results from the GA Depot (a long acting glatiramer acetate) Phase III clinical trial assessing the efficacy, safety and tolerability of a once monthly GA Depot 40 mg compared to placebo in relapsing forms of multiple sclerosis (RMS) patients. Top-line efficacy results showed that GA Depot 40 mg meet the primary endpoint versus placebo in significantly reducing the ARR. The one-year multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo-controlled study in subjects with relapsing forms of multiple sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, IM injection once monthly recruited 1,016 patients at 112 multinational sites.
Top Line Results Highlights
The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066)
Analyses of various secondary efficacy endpoints and safety are ongoing. Following the initial 12-month placebo-controlled period, there is an ongoing one year open-label period extension of the trial.
“We are pleased with the topline results of this study that show the potential of GA Depot 40 mg to offer patients an effective treatment option using a more convenient dosing regimen which may potentially improve compliance and adherence,” said Ehud Marom, CEO and Chairman, Mapi Pharma, “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.”