GA Depot (Long-acting IM Injection of Glatiramer Acetate) Presents Improved Safety and Tolerability Features: Results from a Multinational, Double-blind, Placebo-controlled Phase III Study in Subjects with Relapsing Forms of Multiple Sclerosis
Aaron Miller1, Laura Popper2, Hadar Kolb3, Nadav Kimelman4, Shai Rubnov4, Uri Danon4, Ehud Marom4
1Mt Sinai School Of Med, 2Mapi Pharma Ltd., 3Neurology, Souraski Medical Center, 4Mapi Pharma Ltd
Objective:
Compare GA Depot’s safety and tolerability to Copaxone’s® published data on injection site reactions (ISRs), serious adverse events (SAEs) and immediate post injection reactions (IPIRs).
Background:
Multiple sclerosis (MS) is a chronic disease requiring lifelong therapy. GA Depot is an extended-release formulation containing glatiramer acetate (GA) and administered intramuscularly every 28 days. GA Depot significantly reduced the ARR and MRI activity in MS subjects in the phase III study.
Design/Methods:
GA Depot phase III study AEs/ISRs event rate, were compared to Copaxone®’s annualized ISRs rate published GLACIER study data (a 4-month open-label study). The SAEs incidence was compared to the published GALA study (one-year placebo- controlled phase III study with thrice weekly Copaxone®) and IPIR incidence was compared to Copaxone® US label.
Results:
Overall, in the second treatment year, GA Depot showed a significant reduction in the adverse event rate (number of events/exposures in person-year) compared to the first treatment year: among them: AEs (2.46 vs. 5.89), related AEs (1.80 vs. 4.62), severe AEs (0.01 vs. 0.09). GA Depot showed a much lower ISR rate in the first (2.43) and second (0.98) treatment years, compared to subcutaneous daily GA (70.4) or thrice weekly (35.2). SAEs were reported in 3.7% of GA Depot treated subjects (excluding Covid-19 cases) in the first year and 1.2% in the second treatment year, compared to 4.5% of subjects treated with Copaxone® 40 mg thrice weekly. The incidence of IPIRs is 16% with Copaxone® 20 mg daily and 2% with 40 mg thrice weekly, whereas only 0.8% in GA Depot’s first year and none in the second year.
Conclusions:
This analysis shows favorable safety and tolerability profile of GA Depot compared to daily or thrice weekly use of GA formulation (Copaxone®). These advantages are expected to increase patient adherence and improve patients’ quality of life.