Mapi Pharma Ltd., a partner of generic drugmaker Viatris Inc. ( NASDAQ: VTRS ), announced Wednesday that its Phase 3 clinical trial for GA Depot, a long-acting version of multiple sclerosis therapy Copaxone, reached the primary endpoint.
The trial, designed to evaluate the once monthly intramuscular injection against placebo over 12 months, recruited more than 1,000 patients with relapsing forms of multiple sclerosis (MS) at 112 multinational trial sites.
According to its topline data, GA Depot 40 mg significantly reduced the annualized relapse rate and met the primary endpoint versus placebo.
“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,” said lead investigator Aaron Miller, M.D.
Miller serves as Medical Director at Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology, Icahn School of Medicine in New York.
The investigators are currently evaluating the data for secondary efficacy endpoints and safety. The trial will extend to a one-year open-label period following the initial 12-month placebo-controlled period.
Mapi and Viatris ( VTRS ) expect to work with global regulators to introduce the treatment in major markets.
Read: Seeking Alpha contributor Nathan Aisenstadt with a Neutral rating on VTRS, cites uncertain prospects for the company’s dividend payouts from 2026.
For further details see:
Viatris partner hits main goal in study for long-acting multiple sclerosis therapy