Intramuscular Formulation of Depot Glatiramer Acetate, Dosed Monthly, Reduced Annualized Relapse Rate of Multiple Sclerosis
In a phase 3 study (NCT04121221), a long acting glatiramer acetate (GA depot) (Mapi Pharma, Ziona, Israel) statistically significantly reduced the annualized relapse rate (ARR) by 30.1% compared with placebo (P=.007).
The study was a 12-month, double-blinded, placebo-controlled trial with an enrollment of 1,016 participants with forms of relapsing multiple sclerosis (RMS). Participants were randomized into 2 groups, receiving either 40 mg of GA depot or placebo once every 4 weeks for a total of 13 doses with via intramuscular injection (IM).
“We are pleased with the topline results of this study that show the potential of GA depot 40 mg to offer patients an effective treatment option using a more convenient dosing regimen which may potentially improve compliance and adherence,” said Ehud Marom, chief executive officer and chairman, Mapi Pharma, “We believe the positive results set us on a path to commercialize GA depot and we will work with our partner Viatris to make this potentially valuable new treatment option available to patients with RMS as early as possible. We look forward to providing the other secondary endpoints and overall safety and tolerability of the drug in the near future.”
“The positive top-line efficacy results from the GA depot 40 mg phase 3 trial are an exciting step forward in our long-standing commitment to supporting the needs of the multiple sclerosis community. GA depot has the potential to be complementary to our comprehensive MS portfolio,” said Rajiv Malik, president, Viatris. “We look forward to our continued partnership with Mapi to deliver on our strategy of providing access to more complex and novel products and our mission to empower people worldwide to live healthier at every stage of life.”
“In an international phase 3 double-blind, randomized, placebo-controlled trial, once monthly intramuscular injections of GA depot demonstrated statistically significant efficacy, comparable to other available formulations of GA, that supports its potential designation as a first line therapy for relapsing forms of multiple sclerosis. 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 the study’s principal investigator Aaron Miller, MD, medical director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology, Icahn School of Medicine at Mount Sinai, New York.