AAN 2026: GA Depot may help stabilize disability in RMS and PPMS
Long-acting formulation of glatiramer acetate under regulatory review in EU
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A man stops the domino effect by using his hand to prevent a line of wooden blocks from continuing to fall. (Photo by iStock)
- GA Depot, a long-acting formulation of glatiramer acetate, may stabilize disability in relapsing and primary progressive multiple sclerosis.
- Studies showed stable Expanded Disability Status Scale scores over up to 3 years of follow-up.
- GA Depot is under EU regulatory review; in the U.S., the FDA declined approval for relapsing forms of MS.
Mapi Pharma’s long-acting formulation of glatiramer acetate, GA Depot, may help stabilize disability scores over time in people with both relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS).
That’s according to new analyses of data from an open-label Phase 2a clinical trial (NCT03362294) in PPMS and a pivotal Phase 3 clinical trial (NCT04121221) in relapsing forms of MS.
Across the two studies, people treated with GA Depot showed little to no change in Expanded Disability Status Scale (EDSS) scores — a standard measure of disability in MS — over follow-up periods of up to three years.
The findings were presented in a poster, titled “GA Depot (Long-acting IM Glatiramer Acetate) and its Impact on EDSS in Relapsing Forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS),” at this week’s American Academy of Neurology 2026 annual meeting, which took place in Chicago and online.
“We are very excited to share these positive results for GA Depot in the treatment of MS, where there are significant unmet medical needs,” Ehud Marom, chairman and CEO of Mapi Pharma, said in a company press release.
Potential commercial launch in EU planned for 2027
According to the company, the therapy is currently under regulatory review in Germany for relapsing forms of MS, with a potential commercial launch planned for 2027, if the drug is ultimately approved.
Mapi has also received Good Manufacturing Practice approval from the Israeli Ministry of Health, a manufacturing certification expected to support the company’s plans to bring GA Depot to market in Germany and other European Union (EU) countries.
A global Phase 3 study in PPMS is also being planned.
“We look forward to further evaluating GA Depot in the clinic in the PPMS indication and are currently seeking a co-marketing partner for GA Depot for the [relapsing MS] indication in the EU,” Marom said.
Measure of disability remained stable across 2 clinical trials
GA Depot is a long-acting formulation of glatiramer acetate — the active ingredient in Copaxone and its generics. It’s designed to be given as an intramuscular, or into-the-muscle, injection once every four weeks.
Approved versions of glatiramer acetate, which are indicated for relapsing forms of MS, are administered by subcutaneous (under-the-skin) injection either daily or three times weekly.
Mapi Pharma is investigating its new formulation for the same indications of Copaxone, and also for PPMS, a form of the disease marked by gradually worsening symptoms from onset that has limited treatment options.
A Phase 2a study is investigating GA Depot in 30 adults with PPMS to determine whether the medication is safe and can slow disability accumulation over about three years. The data presented at AAN showed scores remained generally stable over that period: EDSS scores were 5.1 at study start and 4.9 at about three years, indicating a slight reduction in disability levels.
A separate analysis of patients who discontinued the trial early also showed generally stable disability scores, with mean EDSS scores changing from 5.4 at study start to 5.3 at the last available assessment.
The data we are presenting this week at AAN demonstrate that GA Depot can significantly impact disease progression and we believe that this product, once approved, has the potential to transform the treatment landscape for MS.
In the larger Phase 3 trial, which enrolled 1,016 people with relapsing forms of MS, participants received monthly GA Depot or a placebo for one year. Data showed that mean EDSS scores for people treated with GA Depot changed from 2.6 at study start to 2.5 at one year, again indicating stable disability over time.
Again, results were largely replicated in the group of patients who discontinued early, whose EDSS scores were 2.6 at study start and 2.61 at their last assessment.
Statistical analyses also showed a small but statistically significant reduction in EDSS scores with GA Depot relative to a placebo at one year.
In a post hoc analysis, or one planned and conducted after a study has concluded to explore data for new insights, the researchers found that 96.4% of GA Depot-treated patients had no EDSS increase at one year, compared with 91.6% of those on a placebo. This difference was significant, suggesting more patients remained clinically stable on GA Depot treatment.
“The data we are presenting this week at AAN demonstrate that GA Depot can significantly impact disease progression, and we believe that this product, once approved, has the potential to transform the treatment landscape for MS,” Marom said.
In the U.S., Mapi submitted an application to the U.S. Food and Drug Administration seeking the therapy’s approval for relapsing forms of MS. The application was based on data from the pivotal Phase 3 trial, which demonstrated that GA Depot significantly reduced relapse rates by 30.1% and also reduced brain lesions compared with a placebo.
However, the agency declined to approve it in early 2024, signaling the application was not ready for approval in its current form.
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