Mapi Pharma GA Depot Shows Strong MS Progression Control

NESS ZIONA, Israel, April 16, 2026

Mapi Pharma Ltd. has announced new clinical findings demonstrating that its Glatiramer Acetate Depot (GA Depot) long-acting injectable therapy shows promising efficacy in stabilizing disability progression in multiple sclerosis (MS) patients. The data, to be presented at the American Academy of Neurology (AAN) 2026 Annual Meeting, highlight the therapy’s potential to address both Relapsing MS (RMS) and Primary Progressive MS (PPMS), representing a significant advancement in long-term disease management.

Clinical Data Demonstrates Stabilization of Disability Progression

The presented data are derived from two clinical studies, including a Phase IIa open-label study in PPMS patients and a Phase III double-blind, placebo-controlled study in RMS patients, involving over 1,000 participants. The findings showed that GA Depot achieved stabilization of Expanded Disability Status Scale (EDSS) scores, regardless of baseline disease severity, indicating its ability to slow or halt neurological deterioration over time.

Importantly, EDSS stabilization is a critical endpoint in MS research, as it reflects disease progression and long-term patient disability. The results suggest that monthly intramuscular administration of GA Depot may provide sustained therapeutic benefits while reducing treatment burden compared to more frequent dosing regimens. These findings reinforce the therapy’s potential as a long-acting, patient-friendly alternative in MS treatment.

Long-Acting Innovation Enhances Treatment Adherence

GA Depot is a long-acting formulation of glatiramer acetate, a well-established therapy for MS, designed to be administered once every 28 days. This extended dosing schedule offers a significant advantage in improving patient adherence, convenience, and overall treatment experience, particularly in chronic conditions requiring long-term therapy.

The innovation lies in Mapi Pharma’s depot-based delivery platform, which enables controlled release of the active drug over an extended period. This approach not only enhances patient compliance but also ensures consistent drug exposure and therapeutic effect, addressing key challenges in MS management. Additionally, the therapy’s applicability across both RMS and PPMS highlights its broad clinical utility, especially in PPMS where treatment options remain limited.

Regulatory Progress and Commercialization Strategy

Mapi Pharma has reported that GA Depot is currently under final regulatory review in Germany for the RMS indication, with plans to initiate a global Phase III trial for PPMS. The company has also received Good Manufacturing Practice (GMP) approval from the Israeli Ministry of Health, enabling preparations for commercial launch in Europe starting in 2027, followed by broader market expansion in 2028.

These developments indicate strong regulatory momentum and highlight the importance of GxP-compliant manufacturing and clinical development processes in bringing innovative therapies to market. Mapi Pharma is also actively seeking strategic co-marketing partnerships in Europe, reflecting growing interest in the therapy’s commercial potential and its role in addressing unmet medical needs in MS treatment.

Implications for Multiple Sclerosis Treatment Landscape

The introduction of GA Depot represents a significant step forward in the evolution of MS therapies, particularly in the context of long-acting injectable treatments. As the global MS patient population continues to grow, there is an increasing demand for therapies that combine clinical efficacy, safety, and convenience.

By demonstrating EDSS stabilization and long-term disease control, GA Depot has the potential to transform treatment paradigms, offering a more manageable and effective solution for patients and healthcare providers. The therapy’s development also reflects broader trends in the pharmaceutical industry toward life-cycle management, formulation innovation, and patient-centric drug delivery systems, which are critical for improving outcomes in chronic diseases.

The Mapi Pharma GA Depot clinical data underscore the potential of long-acting therapies to redefine MS treatment, combining robust efficacy, improved adherence, and strong regulatory progress. As the therapy advances through late-stage development and regulatory review, it is well-positioned to become a key player in the global MS treatment landscape, addressing both relapsing and progressive forms of the disease.

Source: Mapi Pharma press release