Mapi Pharma Reports Promising Phase II Results for GA Depot in Primary Progressive Multiple Sclerosis
核心洞察
Mapi Pharma (搜索)'s GA Depot demonstrated 96.6% disability progression-free rate in a Phase II study of 30 primary progressive multiple sclerosis (搜索) patients treated for up to three years.
The long-acting glatiramer acetate injection, administered once monthly, showed stable disability scores with mean EDSS improving from 5.1 to 4.5 over three years.
Treatment was well-tolerated with mostly mild adverse events, and the company plans to initiate Phase III trials in 2026 following recent GMP approval.
Mapi Pharma (搜索) Ltd. announced positive Phase II results for GA Depot, a long-acting injection formulation of glatiramer acetate, in patients with primary progressive multiple sclerosis (搜索) (PPMS (搜索)). The data, presented at the ACTRIMS Forum 2026 Conference in San Diego, demonstrated significant clinical benefits in a patient population with limited treatment options.
Clinical Trial Results Show Disease Stabilization
The open-label Phase IIa clinical trial enrolled 30 patients with PPMS (搜索) who received either 25 mg or 40 mg intramuscular injections of GA Depot every 28 days for up to three years. The results revealed that overall disability remained stable over time, with mean Expanded Disability Status Scale (EDSS) scores actually improving slightly from 5.1 at baseline to 4.5 at three years.
Notably, all patients except one did not experience confirmed disability progression over 12 weeks, resulting in a disability progression-free rate of 96.6%. The majority of patients maintained stable physical function, with 89.7% remaining stable on the 9-Hole Peg Test and 79.3% on the Timed 25-Foot Walk. Additionally, 69% of patients showed no evidence of progression, with similar rates observed in both dose groups.
Safety Profile and Tolerability
Treatment with GA Depot was generally well tolerated across the study population. Most adverse events (81.6%) were classified as mild, with the most common being injection site reactions, asthenia, and fever. The safety analysis revealed that adverse events and injection site reaction rates were numerically lower with the 25 mg dose compared to the 40 mg dose. Importantly, no unexpected adverse events were reported during the study period.
Addressing Unmet Medical Need in PPMS
Primary progressive multiple sclerosis (搜索) is characterized by continued worsening neurologic function from the onset of symptoms, without early relapses or remissions. This form of MS represents a significant unmet medical need, as treatment options remain limited compared to relapsing forms of the disease.
"We are very excited to share these positive results for GA Depot in the treatment of PPMS (搜索), where there is a significant unmet medical need," said Ehud Marom, Chairman and Chief Executive Officer of Mapi Pharma (搜索). "The new clinical results we are sharing this week at ACTRIMS demonstrate that GA Depot can significantly impact disease progression. We believe this product, if approved, has the potential to transform the treatment landscape for PPMS."
Development Timeline and Regulatory Progress
GA Depot represents a long-acting injection version of approved glatiramer acetate, commercially available as Copaxone® and Glatopa®. Mapi Pharma (搜索) recently received Good Manufacturing Practice (GMP) approval from the Israeli Ministry of Health, which is mutually recognized by the European Union. This regulatory milestone enables the company to initiate a Phase III study of GA Depot in PPMS (搜索) in 2026.
The company has also established a partnership with Viatris under an exclusive global license agreement to commercialize GA Depot for relapsing forms of multiple sclerosis (搜索), with potential commercial launch planned for 2027 if approved.
Extended-Release Technology Platform
Mapi Pharma (搜索) utilizes extended-release depot technologies for developing long-acting injections as lifecycle management products. The company's approach focuses on existing commercially successful pharmaceuticals across multiple therapeutic areas, including diabetes, weight control, schizophrenia, and oncology, all protected by strong intellectual property positions.