Phase III trial of GA Depot meets primary endpoint in multiple sclerosis
Mapi Pharma announced 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. 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. Mapi Pharma and Viatris plan to work with regulatory authorities in the major markets to determine next steps.
160 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.