Phase 3 Trial of GA Depot as Monthly Relapsing MS Therapy Enrolling in US, Europe

A Phase 3 trial investigating GA Depot, a long-acting, once-a-month injectable formulation of glatiramer acetate, is seeking patients with relapsing forms of multiple sclerosis (MS).

The global study (NCT04121221) aims to include 960 adults, ages 18 to 55, diagnosed with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

Enrollment opened in 2019, with clinical sites in the U.S. and Eastern Europe added since then. More information on contacts and locations can be found here. People in the U.S. who are interested in participating can see if they are eligible here.

GA Depot, developed by Mapi Pharma, is a new formulation of glatiramer acetate that lasts longer in the body and is administered via an intramuscular (into-the-muscle) injection every four weeks. It may be a more convenient alternative to approved formulations of glatiramer acetate (such as Copaxone and generics) that are injected under-the-skin every day or three times a week.

The ongoing trial, supported by a $20 million investment from Mapi’s partner Viatris (formerly known as Mylan), is randomly assigning patients to either 40 mg of GA Depot or a matching placebo, both administered by monthly intramuscular injection. Treatment will continue for about one year (52 weeks) for a maximum of 13 injections.

Those who complete this one-year study will be able to enter its extension, in which all will be treated with GA Depot for a year. More than 600 enrolled patients have been dosed, Mapi reported in late December.

The study’s main goal is to determine whether treatment with GA Depot can lower MS relapse frequency, as assessed with the annualized relapse rate (ARR). Secondary measures include changes in the number and severity of brain lesions visible in MRI scans.

Previous data from Phase 2 studies support that GA Depot may be able to halt MS disability progression, as determined by stable Expanded Disability Status Scale (EDSS) scores for up to three years in both RRMS and PPMS patients.

GA Depot as a once-monthly injection is also being evaluated in an open-label Phase 2 trial (NCT03362294) in people with primary progressive MS (PPMS).  Enrollment is underway at seven sites in Israel and two in the Republic of Moldova. More information is available here.