ACTRIMS 2023: GA Depot found to ease MS disability in Phase 3 trial
Long-acting glatiramer acetate therapy also helps reduce relapse rates
GA Depot, an experimental long-acting version of glatiramer acetate, significantly reduced relapse rates and prevented the development of new lesions among people with relapsing forms of multiple sclerosis, according to new data from a Phase 3 clinical trial.
Disability levels also were significantly reduced with the treatment, given via monthly injections, as compared with a placebo.
According to researchers, these findings suggest that GA Depot may serve as a more convenient alternative to Copaxone, an approved version of glatiramer acetate that is given either once daily or three times per week via under-the-skin (subcutaneous) injections.
“The results of this trial are very, very comparable to the clinical trial results originally reported with” Copaxone, Aaron Miller, MD, the study’s lead investigator, said in a poster presentation at the recent Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, held in San Diego. Miller is a professor of neurology at the Icahn School of Medicine at Mount Sinai, and medical director of the Corinne Goldsmith Dickinson Center for MS, both in New York.
New data mirror top-line results
Miller’s poster was titled, “Results of a Phase III, Multinational, Double Blind, Placebo-Controlled Study in Subjects with Relapsing Forms of Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of GA Depot, a Long-Acting IM Injection of Glatiramer Acetate, Administered Once Every Four Weeks.” The trial was funded by Mapi Pharma, the developer of GA Depot.
Aaron Miller, MD, professor at the Icahn School of Medicine and medical director of the Corinne Goldsmith Dickinson Center for MS at Mount Sinai
“Glatiramer acetate is a drug that’s been available for roughly 30 years now, and has been one of the mainstays for treatment of MS,” Miller said, adding, “Its disadvantage is that it’s given by self-injection three times a week, so 13 injections a month.”
GA Depot was designed to provide glatiramer acetate in a more convenient manner; it’s administered with a once per month injection into the muscle.
The treatment contains extended-release microspheres, or tiny particles that release small amounts of the medication over an extended period of time, which allows the treatment to be delivered less frequently.
The ongoing Phase 3 clinical trial (NCT04121221) enrolled 1,016 people with relapsing-remitting MS and active secondary progressive MS, ages 18-55, who had experienced at least one relapse in the year prior to the study or two relapses in the previous two years.
Participants were randomly assigned to receive 40 mg GA Depot or a placebo, once per month for one year, for a total of 13 injections.
In September, Mapi announced the trial had met its primary goal of showing that GA Depot could significantly reduce the rate of relapses, by 30.1%, which Miller said “was very comparable to what we saw in the [original] clinical trials of glatiramer acetate.”
During the one-year trial, participants given a placebo had experienced on average 0.26 relapses per year, while those assigned the investigational therapy experienced 0.182 relapses per year.
In the poster, Miller also reported additional outcomes related to secondary trial goals. In particular, GA Depot was associated with a significant reduction, of 28.5%, in the number of inflammatory brain lesions among patients compared with a placebo. The results also showed a 17.3% reduction in new or enlarging lesions.
Moreover, participants given GA Depot experienced a slowing in disability accumulation, as suggested by smaller increases in Expanded Disability Status Scale (EDSS) scores.
Safety findings were similar to those seen with Copaxone and its generics, with no new safety signals reported.
The most common treatment-emergent adverse event was infusion site reactions. While those did occur at a higher rate in the GA Depot group (46.1%) compared with the placebo group (28.7%), most reactions were mild.
Data support GA Depot as new MS treatment
According to the researchers, the trial data overall support the use of GA Depot as a disease modifying therapy for relapsing types of MS — and could offer “a preferable schedule than current regimens of [glatiramer acetate], potentially leading to improved patient satisfaction and treatment.”
Such a schedule could lessen the burden on patients, Miller said.
“What patient, already on glatiramer acetate, taking 13 injections a month might not want to switch to a product that they can take once a month, that delivers results that are very comparable, and has a comparably excellent safety record, ” Miller said.
“In addition to that, [GA Depot] is potentially — if it ultimately is approved — a product that could be as initial therapy for a person who wants a very safe drug, and particularly for a patient who doesn’t look like he or she has a very aggressive MS,” he added.
Among participants who completed the main trial, 93.4% opted to join an ongoing open-label extension phase, in which all are being treated with GA Depot for one year.
This open-label phase is important “because it tells us something about the tolerability of the drug,” Miller said, noting that the high rate of participation in the extension, “means they [the participants] were not experiencing prominent discomfort from the injections.”
In light of the promising results, Miller said he believes Mapi will prepare a submission to the U.S. Food and Drug Administration (FDA) requesting the approval of GA Depot.
“The next step will be up to the FDA,” he said.
Note: The Multiple Sclerosis News Today team is providing in-depth coverage of the ACTRIMS Forum 2023 Feb. 23–25. Go here to see the latest stories from the conference. Follow along on Facebook, Twitter, and Instagram for live updates using the hashtag #actrims2023.
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