Contributions
Abstract: P1777
Type: Poster Sessions
Abstract Category: N/A
Background: Multiple sclerosis (MS) is a chronic disease, requiring lifelong therapy. While several disease-modifying treatments (DMTs) have been developed and approved, low treatment adherence, which leads to sub-optimal clinical outcomes, remains an unmet need. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, intended for administration once every 28 days. Results of a GA Depot phase IIa one-year core study in relapsing remitting MS (RRMS) patients suggest that GA Depot treatment was safe, tolerable and efficacious.
Objective: Assess the safety, tolerability and efficacy by proportion of patients with No Evidence of Disease Activity (NEDA, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI) at two years of treatment with GA Depot in a subgroup of 13 RRMS patients who completed the core study and continued through the study extension.
Design and 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 intramuscularly every 28 days, at doses of 80mg or 40mg in the core study (52 weeks) and 40mg in the study extension (additional 48 weeks).
Results: Adverse events (AEs) mainly included mild injection site reactions and no unexpected AEs were reported. Overall, the number of AEs was reduced during the second year. No immediate post-injection reactions, as reported with other GA preparations, were detected. Patients received all injections as per protocol. Data analyzed by per protocol population (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had two relapses during the two-year study. No MRI activity was noted in all patients during that period. Two years NEDA was achieved by 81.8% of the patients.
Conclusions: Encouraging results of the GA Depot two-year study support the product's safety, tolerability, and efficacy in this study cohort. It further supports the assumption of GA Depot's potential to improve MS treatment by significantly reducing frequency of injections, increasing adherence and providing a therapeutic benefit.
Disclosure: Study Supported by: Mapi Pharma Ltd.
Disclosure: Prof. Ariel Miller participated as the core-study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter participated as the extension-study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
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, and founder and CEO of Mapi Pharma.
Abstract: P1777
Type: Poster Sessions
Abstract Category: N/A
Background: Multiple sclerosis (MS) is a chronic disease, requiring lifelong therapy. While several disease-modifying treatments (DMTs) have been developed and approved, low treatment adherence, which leads to sub-optimal clinical outcomes, remains an unmet need. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, intended for administration once every 28 days. Results of a GA Depot phase IIa one-year core study in relapsing remitting MS (RRMS) patients suggest that GA Depot treatment was safe, tolerable and efficacious.
Objective: Assess the safety, tolerability and efficacy by proportion of patients with No Evidence of Disease Activity (NEDA, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI) at two years of treatment with GA Depot in a subgroup of 13 RRMS patients who completed the core study and continued through the study extension.
Design and 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 intramuscularly every 28 days, at doses of 80mg or 40mg in the core study (52 weeks) and 40mg in the study extension (additional 48 weeks).
Results: Adverse events (AEs) mainly included mild injection site reactions and no unexpected AEs were reported. Overall, the number of AEs was reduced during the second year. No immediate post-injection reactions, as reported with other GA preparations, were detected. Patients received all injections as per protocol. Data analyzed by per protocol population (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had two relapses during the two-year study. No MRI activity was noted in all patients during that period. Two years NEDA was achieved by 81.8% of the patients.
Conclusions: Encouraging results of the GA Depot two-year study support the product's safety, tolerability, and efficacy in this study cohort. It further supports the assumption of GA Depot's potential to improve MS treatment by significantly reducing frequency of injections, increasing adherence and providing a therapeutic benefit.
Disclosure: Study Supported by: Mapi Pharma Ltd.
Disclosure: Prof. Ariel Miller participated as the core-study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
Dr. Shlomo Flechter participated as the extension-study Coordinating Principal Investigator and as a site Principal investigator (PI) in the study funded by Mapi Pharma.
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, and founder and CEO of Mapi Pharma.