GA Depot Reduces Relapse Rates in Phase 3 Clinical Trial

Treatment with GA Depot, an experimental long-acting form of glatiramer acetate that requires less frequent dosing than approved formulations, significantly reduced relapse rates among people with relapsing forms of multiple sclerosis (MS), according to top-line results from a Phase 3 clinical trial.

“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,” Ehud Marom, CEO and chairman at Mapi Pharma, said in a press release announcing the results.

Mapi, the company developing GA Depot, sponsored the trial with support from a $20 million investment by Viatris.

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“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 [relapsing] MS as early as possible,” Marom said.

Formulations of glatiramer acetate, namely the brand name Copaxone and its generics, are already approved for the treatment of relapsing MS. These therapies are administered via injection under the skin once per day or several times per week. GA Depot is a long-acting formulation of the medication designed to be administered by injection into muscle once a month.

“The monthly administration of GA Depot should offer patients a much more preferable schedule than current regimens of [glatiramer acetate], a long-standing pillar in the treatment of MS, and lead to improved patient satisfaction and medication adherence,” said Aaron Miller, MD, of the Icahn School of Medicine at Mount Sinai in New York.

The Phase 3 clinical trial (NCT04121221) enrolled 1,016 people with relapsing types of MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

Participants were assigned randomly to receive 40 mg GA Depot or a placebo once a month for one year (13 injections in total). The study’s main goal was to test whether GA Depot treatment could reduce the annual rate of relapses — periods when existing symptoms suddenly worsen or new symptoms appear.

Top-line results showed the trial met that goal, with GA Depot reducing the relapse rate significantly — by 30.1% compared with a placebo.

According to Miller, who served as principal investigator for the clinical trial, this effect is “comparable to other available formulations” of glatiramer acetate, and “supports its [GA Depot’s] potential designation as a first line therapy for relapsing forms of multiple sclerosis.”

Analyses of secondary efficacy goals and safety are ongoing.

“We look forward to providing the other secondary endpoints and overall safety and tolerability of the drug in the near future,” Marom said.

The companies are planning to work with regulatory authorities to determine the next steps in the development and commercialization of GA Depot.