Glatiramer Acetate Depot (extended-release) Phase IIa one-year study in patients with Relapsing-remitting Multiple Sclerosis: Safety, tolerability and efficacy - NEDA Analysis (P6.359) Academic Article uri icon

abstract

  • Objective: Assess the safety, tolerability and efficacy of GA Depot in RRMS patients. Background: Multiple sclerosis (MS) is a chronic disease, requiring lifelong therapy for which adherence is still a major challenge. While several disease-modifying treatments (DMTs) have been developed and approved, still, unmet need remains in MS to improve patient outcomes, by improving treatment efficacy, tolerability and adherence. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, which is released from its formulation continuously over 30 days. MOG-EAE data has shown that GA Depot is as effective as Copaxone®. Design/Methods: Main eligibility criteria included: age 18–70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to study enrollment. Patients received GA Depot IM (80 mg, 40 mg) every 28 days for up to 52 weeks. Results: Twenty-five RRMS patients were enrolled as follows: 80 mg dose (n=12) and 40 mg dose (n=13). Overall, 72% of study population were female, mean MS duration was 15.5±8.3 years and mean EDSS score was 2.4±1.6, at baseline. Adverse events (AEs) mainly included mild injection site reactions (ISRs) and no unexpected AEs were reported. Statistically significant fewer ISRs were reported with the 40 mg dose than with the 80 mg dose. No immediate post-injection reactions, as recorded with GA (Copaxone®), were detected. A Composite outcome: No Evidence of Disease Activity (NEDA), defined as: no relapses, no 12-week confirmed disability progression and no new lesions or no gadolinium-enhancing lesions was achieved by 84.6% (per protocol population) in this GA Depot phase II one-year trial. Conclusions: The GA Depot one-year encouraging results support the assumption of its potential to improve MS treatment by significantly reducing number of injections, increasing adherence and providing a therapeutic benefit. GA Depot’s safety, tolerability and encouraging efficacy data prompts the continuation to one phase III pivotal trial. Study Supported by: Mapi Pharma Ltd. Disclosure: Dr. Miller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Merck, TEVA, MAPI-PHARMA. Dr. Miller has received research support from Biogen, MERCK, TEVA. Dr. Popper has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mapi Pharma Ltd. Dr. Danon has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mapi Pharma Ltd. Dr. Bleich Kimelman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mapi Pharma Ltd. Dr. Rubnov has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mapi Pharma Ltd. Dr. Marom has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mapi Pharma. Dr. Chapman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva, Roche, Sanofi Genzyme. Dr. Shifrin has nothing to disclose. Dr. Milo has nothing to disclose. Dr. Karussis has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Kabi Pharmacia, Merck/EMD Serono, Novartis, Roche, Sanofi-Genzyme, Roche and Teva Pharmaceutics and Neuroscience. Dr. Karussis has received research support from Biogen Idec, Kabi Pharmacia, Merck/EMD Serono, Novartis, Roche, Sanofi-Genzyme, Roche and Teva Pharmaceutics and Neuroscience. Dr. Milo has nothing to disclose. Dr. Hoffmann has nothing to disclose. Dr. Flechter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche. Dr. Karni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Roche, Stem cell Medicine. Dr. Karni has received research support from Merck, Sanofi.

publication date

  • January 1, 2018