Mapi Pharma's Once-Monthly MS Drug Shows Promise in Slowing Disability

NESS ZIONA, Israel – April 16, 2026 – Mapi Pharma, a clinical-stage biopharmaceutical company, is set to present compelling new data at the American Academy of Neurology (AAN) Annual Meeting, suggesting its long-acting injectable for multiple sclerosis (MS) can significantly slow disability progression in both relapsing and progressive forms of the disease. The findings position the drug, GA Depot, as a potentially transformative, once-monthly treatment option for a condition that affects millions worldwide.

The data, to be unveiled in Chicago, stems from two major clinical studies of Glatiramer Acetate Depot (GA Depot), a novel formulation of the well-established MS therapy glatiramer acetate, commercially known as Copaxone®. The results indicate that the treatment stabilizes disability levels, as measured by the Expanded Disability Status Scale (EDSS), a critical benchmark for tracking MS progression. This effect was observed in patients with both relapsing forms of multiple sclerosis (RMS) and the more challenging primary progressive multiple sclerosis (PPMS).

A New Era of Convenience and Adherence

For decades, patients with relapsing MS have relied on glatiramer acetate, a therapy that requires daily or thrice-weekly subcutaneous injections. While effective, this frequent dosing schedule can be a significant burden, often leading to injection fatigue and reduced adherence over the long term. Mapi Pharma's GA Depot aims to revolutionize this standard of care by offering the same therapeutic agent in a once-every-28-days intramuscular injection.

This shift to a monthly schedule represents a substantial improvement in convenience and quality of life. Clinical data supports not only the drug's efficacy but also its tolerability. In the pivotal one-year Phase III study involving over 1,000 RMS patients, treatment was generally well-tolerated, with most adverse events reported as mild. The most common side effects were injection site reactions and mild fever, consistent with the known profile of glatiramer acetate. Furthermore, the trial demonstrated a high compliance rate of 99%, underscoring the potential benefits of a less frequent dosing regimen in maintaining long-term treatment.

Beyond convenience, the clinical data for RMS is robust. The Phase III trial showed a 28.5% reduction in new enhancing brain lesions and a 17.3% reduction in new or enlarging lesions, alongside the crucial finding of EDSS stabilization. These results suggest that the long-acting formulation maintains, and may even enhance, the therapeutic benefits seen in its shorter-acting predecessors, offering patients a powerful combination of efficacy and convenience.

Targeting a Critical Unmet Need in Progressive MS

Perhaps the most significant aspect of the upcoming AAN presentation is the data related to primary progressive multiple sclerosis. PPMS is a debilitating form of the disease characterized by steady neurological decline from onset, without the periods of relapse and remission seen in RMS. Treatment options for PPMS are scarce, with only one drug, Ocrevus (ocrelizumab), currently approved to slow its progression.

Mapi Pharma's findings from its open-label, Phase IIa study in 30 PPMS patients offer a new ray of hope. Over a three-year period, patients treated with GA Depot showed stable EDSS scores, with the mean score even improving slightly from 5.1 at baseline to 4.5. An impressive 69% of patients showed no evidence of progression (NEP), and the vast majority maintained stable physical function. According to neurologists not directly involved with the study, any intervention that can demonstrably stabilize or slow the relentless progression of PPMS is considered a major clinical advancement.

The stabilization of disability, regardless of a patient's baseline EDSS score, is particularly noteworthy. It suggests GA Depot could offer a meaningful benefit across a broad spectrum of PPMS patients, addressing a profound unmet medical need. Buoyed by these promising results, Mapi Pharma is now planning a global Phase III study to further validate these findings in a larger PPMS patient population, a move that could pave the way for a much-needed new therapeutic option.

Navigating a Competitive European Market

With promising data in hand, Mapi Pharma is strategically positioning GA Depot for a major market entry, starting with Europe. The drug is currently in the final stages of the review process in Germany for the RMS indication, with a commercial launch anticipated in 2027. This will be followed by a broader rollout to other EU countries in early 2028, facilitated by a Good Manufacturing Practice (GMP) approval from the Israeli Ministry of Health, which is recognized by the European Union.

The company is entering a competitive but lucrative MS market, where the glatiramer acetate segment alone is valued at an estimated $20 billion. While Teva's Copaxone® is the established incumbent, GA Depot's once-monthly dosing is a powerful differentiator that could capture significant market share. To bolster its commercial strategy, Mapi is actively seeking a co-marketing partner for the RMS indication in the EU. Such partnerships are common in the pharmaceutical industry, allowing a company to leverage a partner's established sales force and market access to accelerate uptake. This follows an existing global license agreement with Viatris to commercialize the drug for RMS, indicating a multi-pronged approach to maximizing the product's reach.

"We are very excited to share these positive results for GA Depot in the treatment of MS, where there are significant unmet medical needs," said Ehud Marom, Chairman and CEO of Mapi Pharma, in the company's official statement. "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."

The company's focus on long-acting depot injectables extends beyond MS. Its pipeline includes complex formulations for antipsychotics and GLP-1 agonists for diabetes and weight management, showcasing a deep expertise in this specialized delivery technology. This underlying platform strength, combined with its fully integrated R&D and manufacturing capabilities, positions Mapi Pharma as a formidable player in the development of high-value, lifecycle-managed products. As company management prepares to meet with potential partners and collaborators at the AAN conference, the data on GA Depot serves as a powerful testament to its scientific and commercial potential, heralding a possible new chapter in the management of multiple sclerosis.