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.
“Through this partnership, and based on the excellent progress to date in launching the Phase 3 study and enrolling patients, we are confident in our ability to successfully bring to market our GA-Depot product,” Marom added.
Mapi is increasing the capacity of its manufacturing facility to supply GA Depot for commercial use if approved by the FDA.
“Through this latest equity participation in Mapi, we are further strengthening our partnership and remain highly confident in the science and the progress of the program behind this long-acting GA product. We look forward to the Phase 3 study outcomes and are committed to bringing GA Depot to market at the earliest opportunity,” said Rajiv Malik, president of Mylan.
Mylan markets an approved generic version of glatiramer acetate, available both as a 20 mg/mL daily injection treatment and as a 40 mg/mL injection three times a week.
GA Depot is also being tested as a possible treatment for those with primary progressive MS (PPMS) in a Phase 2 trial (NCT03362294) underway in Israel. Patient enrollment is ongoing at four clinical sites, and more information is available here.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?