▎Editor of WuXi AppTec content team

Recently, Mapi Pharma announced that its drug GA Depot has achieved positive top-line results
in a Phase 3 clinical trial for patients with recurrent multiple sclerosis (RMS).

The study reached the primary endpoint, with a significant 30.
1%
reduction in annual recurrence rates in patients treated with GA Depot compared to the placebo-controlled group.

Multiple sclerosis is a demyelination of the nervous system that affects multiple parts of the body and is the leading cause of non-traumatic neurological disability in young people, with the main pathological features including inflammatory demyelination, gliosis, and neurodegeneration
.

GA Depot is a long-acting injectable formulation of the approved drug gratiram acetate (trade name Copaxone) of Mapi Pharma with a regimen of 13 injections every four weeks for the treatment of recurrent multiple sclerosis
.

In this Phase 3 clinical trial, the researchers evaluated the efficacy, safety, and tolerability of the GA Depot regimen at a once-monthly dose of 40 mg in RMS
patients.

The study was a 1-year randomized, double-blind, placebo-controlled, multicenter Phase 3 trial that enrolled 1,016 RMS patients
in 112 trial centers worldwide.

According to the latest top-line data, the study has reached the primary endpoint, and GA Depot treatment significantly reduces the annual recurrence rate
in patients compared with the placebo control group.

Currently, studies and safety analysis of each secondary efficacy endpoint are ongoing
.

After completing the initial 12-month placebo-controlled trial, the researchers are conducting a one-year open-label extended trial
.

Image source: 123RF

"We are very pleased with the top-line results of this study, which suggests that a 40 mg GA Depot has the potential to provide patients with an effective treatment option and that adopting a more convenient mode of administration may potentially improve patient compliance
.

It is understood that Mapi Pharma and Viatrice are planning to work closely with regulators to determine the next move
.

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