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Abstract Details

Results of a Phase III, Multinational, Double-blind, Placebo-controlled Study in Subjects with Relapsing Forms of Multiple Sclerosis (RMS) to Assess the Efficacy, Safety, and Tolerability of GA Depot Administered Once Every Four Weeks
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-014

GA Depot consists of extended-release microspheres administered intramuscularly every 28 days.  

To assess efficacy, safety and tolerability of GA Depot, a long-acting IM injection of glatiramer acetate, administered every four weeks, compared to placebo in a phase III randomized double-blind study in subjects with relapsing multiple sclerosis (RMS).

 1,016 subjects received GA Depot 40mg or placebo every four weeks for 52 weeks. Subjects were age 18-55 years and experienced at least one relapse in 12 months prior to screening or two relapses in 24 months prior. Primary endpoint was annualized relapse rate (ARR); secondary endpoints were MRI based. An optional open label extension study was available to subjects completing RCT.

Baseline characteristics were similar between arms. Primary analysis showed  statistically significant (p=0.0066) reduction of 30% of ARR for the GA Depot arm compared to placebo. The 1st secondary endpoint of cumulative T1 new enhancing lesions showed statistically significant (p=0.0083) reduction of 28.5% in the GA Depot arm. The 2nd secondary endpoint post-hoc analysis of cumulative number of new or newly enlarging hyperintense T2 lesions at week 52 showed statistically significant (p= 0.0305) reduction of 17.3% for GA Depot subjects. Mean EDSS showed consistent statistically significant (p=0.0193) reduction. The GA Depot arm had an expected higher incidence of treatment emergent adverse events (TEAEs). Most common TEAEs were injection site reactions (ISR), mostly mild. For patients remaining in the study the observed compliance rate is ~99%. 

The significant treatment effect of GA Depot in reducing ARR (30%, p=0.0066), strengthened by MRI endpoints, supports the use of GA Depot as a DMT for RMS patients. GA Depot offer a preferable schedule than current regimens of GA leading to improved patient satisfaction and treatment. GA Depot administration regime is expected to result in fewer ISRs than other GA products.

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 $50,000-$99,999 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 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 $5,000-$9,999 for serving as a Consultant for Alexion. 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 $10,000-$49,999 for serving as an Expert Witness for confidential. 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.
Joseph R. Berger, MD, FAAN Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb/Celgene. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono/Merck. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen/J&J. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Morphic. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuVIR. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seagen. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cellevolve. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MAPI. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ExcisionBio. Dr. Berger has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for WebMD. The institution of Dr. Berger has received research support from Biogen. The institution of Dr. Berger has received research support from Genentech/Roche.
Nadav Bleich Kimelman Nadav Bleich Kimelman has nothing to disclose.
Shai Rubnov Shai Rubnov has received personal compensation for serving as an employee of Mapi pharma.
Uri Danon Uri Danon has received personal compensation for serving as an employee of Mapi Pharma Ltd..
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.