Mapi Pharma, supported by an additional $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate.
The study (NCT04121221), which opened in October 2019, aims to generate evidence to support a request for GA Depot’s approval to treat people with relapsing multiple sclerosis, which includes clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
According to a Mapi Pharma press release, patient enrollment in the trial is progressing well, with more than 170 people dosed in the 56 clinical sites across the U.S. and Europe where the study is currently underway. In total, almost 1,000 patients are expected to participate; contact and site details can be found here.
In the trial, participants will be randomly assigned to either 40 mg of GA Depot or a matching placebo, both administered through a once monthly intramuscular injection for about one year.
Patients who complete the initial 52-week treatment course will have the option to enroll in an open-label extension study to either continue or start with GA Depot treatment for a year.
To assess GA Depot’s ability to prevent MS relapses and disease progression, trial investigators will evaluate changes in the annualized relapse rate during the first year of treatment, as well as changes in the number and severity of MS lesions visible in MRI scans.
If successful, the trial will support Mapi’s submission of a new drug application to the U.S. Food and Drug Administration (FDA) requesting the approval of its long-acting version of Copaxone (glatiramer acetate, by Teva) for relapsing forms of MS.
“Mapi Pharma and Mylan share a commitment to improve the lives of MS patients, and I am pleased that Mylan has expressed its continued confidence in our development program for GA-Depot,” Ehud Marom, chairman and CEO of Mapi, said in the release.
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