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
Shlomo Flechter1, Ariel Miller2,3, Laura Popper 4, Nadav Bleich Kimelman4, Shai Rubnov 4, Uri Danon 4, Ehud Marom4, Ron Milo5,6, Joab Chapman7,8, Alla Shifrin9, Ronit Gilad10, Chen Hoffmann7, Dimitrios Karussis11, Arnon Karni8,12
1Shamir (Assaf Harofeh) Medical Center, 2Technion-Israel Institute of Technology, 3Carmel Medical Center, 4Mapi-Pharma Ltd., 5Barzilai Medical Center, 6, Ben-Gurion University of the Negev, 7Sheba Medical Center, 8Tel Aviv University, 9Rambam Medical Center, 10Kaplan Medical Center, 11Hadassah HMO, 12Ichilov Medical Center
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.
Background:
MS is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. 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.
Design/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:
AEs mainly included mild injection site reactions. No unexpected AEs were reported. 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 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.