Contributions
Abstract: P1899
Type: Poster
Abstract Category: Late breaking news
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®. Objective: Assess the safety, tolerability and efficacy of GA Depot in RRMS patients.
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 (80mg, 40mg) every 28 days for up to 52 weeks.
Results: Twenty-five RRMS patients were enrolled as follows: 80mg dose (n=12) and 40mg 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 40mg dose than with the 80mg 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:
Prof. Ariel Miller participated as the study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter, Dr. Ron Milo, Prof. Joab Chapman, Dr. Alla Shifrin, Prof. Ronit Gilad, Prof. Dimitrios Karussis and Dr. Arnon Karni participated as PIs in the study funded by Mapi Pharma.
Dr. Chen Hoffmann participated as the central reading MRI facility in the study funded by Mapi Pharma.
Laura Popper, Nadav Bleich Kimelman, Shai Rubnov (co-inventor of GA Depot) and Uri Danon are employed by Mapi Pharma. Ehud Marom is a co-inventor of GA Depot, founder, and the CEO of Mapi Pharma.
Abstract: P1899
Type: Poster
Abstract Category: Late breaking news
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®. Objective: Assess the safety, tolerability and efficacy of GA Depot in RRMS patients.
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 (80mg, 40mg) every 28 days for up to 52 weeks.
Results: Twenty-five RRMS patients were enrolled as follows: 80mg dose (n=12) and 40mg 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 40mg dose than with the 80mg 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:
Prof. Ariel Miller participated as the study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter, Dr. Ron Milo, Prof. Joab Chapman, Dr. Alla Shifrin, Prof. Ronit Gilad, Prof. Dimitrios Karussis and Dr. Arnon Karni participated as PIs in the study funded by Mapi Pharma.
Dr. Chen Hoffmann participated as the central reading MRI facility in the study funded by Mapi Pharma.
Laura Popper, Nadav Bleich Kimelman, Shai Rubnov (co-inventor of GA Depot) and Uri Danon are employed by Mapi Pharma. Ehud Marom is a co-inventor of GA Depot, founder, and the CEO of Mapi Pharma.