Abstract Details

Title 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

Topic Multiple Sclerosis

Presentation(s) P8 - Poster Session 8 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-018

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.

Authors/Disclosures
Aaron E. Miller, MD, FAAN (Mt Sinai School Of Med) PRESENTER	Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Accordant Health Services (Caremark). Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Corevitas (formerly known as Corrona). Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MAPI=Pharma. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Viatris (Mylan). Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gerson Lehrman Group. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen (Horizon Therapeutics). Dr. Miller has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Sterne Kessler. Dr. Miller has received publishing royalties from a publication relating to health care.
Laura Popper, MD (Mapi Pharma Ltd.)	Dr. Popper has received personal compensation for serving as an employee of Mapi Pharma.
Hadar Kolb	Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Hadar Kolb has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for MAPI pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neopharm Scientific. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Marck. The institution of Hadar Kolb has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MAPI pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medison pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Marck.
Nadav Bleich Kimelman	Nadav Bleich Kimelman has nothing to disclose.
Shai Rubnov	Shai Rubnov has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Mapi pharma.
Uri Danon	Uri Danon has received personal compensation for serving as an employee of Mapi harma.
Ehud Marom	Mr. Marom has received personal compensation for serving as an employee of Mapi Pharma. Mr. Marom has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Mapi Pharma. Mr. Marom has stock in Mapi Pharma. Mr. Marom has received intellectual property interests from a discovery or technology relating to health care.

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