Glatiramer acetate depot (extended-release) Phase IIa study in patients with relapsing remitting multiple sclerosis: safety, tolerability and efficacy (no evidence of disease activity) subpopulation three-years analysis
ECTRIMS Online Library. Flechter S. 09/13/19; 278686; P1647
Shlomo Flechter
Shlomo Flechter
Contributions
Abstract

Abstract: P1647

Type: Poster Sessions

Abstract Category: Poster Session 3

S. Flechter1, A. Miller2,3, L. Popper4, N. Bleich Kimelman4, S. Rubnov4, U. Danon4, E. Marom4, R. Milo5,6, J. Chapman7,8, A. Shifrin9, R. Gilad10, C. Hoffmann11, D. Karussis12, A. Karni8,13

1Multiple Sclerosis Clinical Research and Therapy Service, Department of Neurology, Shamir (Assaf Harofeh) Medical Center,, Zerifin, 2Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, 3Multiple Sclerosis & Brain Research Center, Carmel Medical Center, Haifa, 4Mapi Pharma LTD, Ness Ziona, 5Department of Neurology, Barzilai University Medical Center, Ashkelon, 6Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, 7Department of Neurology, Sheba Medical Center, Ramat Gan, 8Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, 9Department of Neurology, Rambam Medical Center, Haifa, 10Department of Neurology, Kaplan Medical Center, Rehovot, 11Diagnostic and Interventional Imaging, Sheba Medical Center, Ramat Gan, 12Unit of Neuroimmunology-MS Center, Hadassah Medical Center, Ein Kerem, Jerusalem, 13Neuroimmunology Clinic, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Background: Multiple sclerosis is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, administered intramuscularly once every 28 days. Results of GA Depot phase IIa one-year core study and two years extension period in relapsing remitting MS (RRMS) suggest that GA Depot is safe, tolerable and efficacious.
Objective: Assess the safety, tolerability and efficacy by NEDA, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI after three years of treatment with GA Depot in the subpopulation of 11 RRMS patients who completed the core study and continued through two years of the study extension.
Design and methods
: Eligibility criteria included: age 18-70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to enrollment. Patients received GA Depot at doses of 80mg or 40mg in the core study and 40mg in the study extension.
Results
: Adverse events (AEs) mainly included mild injection site reactions. No unexpected AEs were reported. The number of AEs was significantly reduced during the second and third year. No systemic immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by intention to treat population (mITT) (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had 3 relapses during the three-year study. No MRI activity was noted during that period. Three years NEDA was achieved by 81.8% of the patients (mITT) or 90% of the per protocol population.
Conclusions: Encouraging results of the GA Depot three-year study support its 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: P1647

Type: Poster Sessions

Abstract Category: Poster Session 3

S. Flechter1, A. Miller2,3, L. Popper4, N. Bleich Kimelman4, S. Rubnov4, U. Danon4, E. Marom4, R. Milo5,6, J. Chapman7,8, A. Shifrin9, R. Gilad10, C. Hoffmann11, D. Karussis12, A. Karni8,13

1Multiple Sclerosis Clinical Research and Therapy Service, Department of Neurology, Shamir (Assaf Harofeh) Medical Center,, Zerifin, 2Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, 3Multiple Sclerosis & Brain Research Center, Carmel Medical Center, Haifa, 4Mapi Pharma LTD, Ness Ziona, 5Department of Neurology, Barzilai University Medical Center, Ashkelon, 6Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, 7Department of Neurology, Sheba Medical Center, Ramat Gan, 8Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, 9Department of Neurology, Rambam Medical Center, Haifa, 10Department of Neurology, Kaplan Medical Center, Rehovot, 11Diagnostic and Interventional Imaging, Sheba Medical Center, Ramat Gan, 12Unit of Neuroimmunology-MS Center, Hadassah Medical Center, Ein Kerem, Jerusalem, 13Neuroimmunology Clinic, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Background: Multiple sclerosis is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, administered intramuscularly once every 28 days. Results of GA Depot phase IIa one-year core study and two years extension period in relapsing remitting MS (RRMS) suggest that GA Depot is safe, tolerable and efficacious.
Objective: Assess the safety, tolerability and efficacy by NEDA, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI after three years of treatment with GA Depot in the subpopulation of 11 RRMS patients who completed the core study and continued through two years of the study extension.
Design and methods
: Eligibility criteria included: age 18-70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to enrollment. Patients received GA Depot at doses of 80mg or 40mg in the core study and 40mg in the study extension.
Results
: Adverse events (AEs) mainly included mild injection site reactions. No unexpected AEs were reported. The number of AEs was significantly reduced during the second and third year. No systemic immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by intention to treat population (mITT) (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had 3 relapses during the three-year study. No MRI activity was noted during that period. Three years NEDA was achieved by 81.8% of the patients (mITT) or 90% of the per protocol population.
Conclusions: Encouraging results of the GA Depot three-year study support its 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.

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