Abstract Details

Title Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with Relapsing Remitting Multiple Sclerosis: Safety, Tolerability and Efficacy (No Evidence of Disease Activity) Two-Years Analysis

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-052

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 two years of treatment with GA Depot in 13 RRMS patients who completed the core study and continued through the study extension.

Background Multiple sclerosis (MS) is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, low 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 in relapsing remitting MS (RRMS) suggest that GA Depot was 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 (additional 48 weeks).

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 year. No immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by per protocol population (n=11): Mean EDSS score after two years showed no significant change compared to baseline. One patient had two relapses during the two-year study. No MRI activity was noted in all patients during that period. Two years NEDA was achieved by 81.8% of the patients.

Conclusions

Encouraging results of the GA Depot two-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.

Authors/Disclosures
Shlomo Flechter, MD, FAAN (Outpatient Clinic) PRESENTER	Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma.
Ariel L. Miller, MD, PhD	Dr. Miller has nothing to disclose.
Laura Popper, MD (Mapi Pharma Ltd.)	Dr. Popper has received personal compensation for serving as an employee of Mapi Pharma.
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.
Ron E. Milo, MD, FAAN (Barzilai Medical Center)	Dr. Milo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck KGaA . Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck-Serono. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brystol-Myers-Squibb . Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medison. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Brystol-Myers-Squibb.
Joab Chapman, MD, PhD (Sheba Medical Center)	Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merk Serono. The institution of Dr. Chapman has received research support from Ministry Of Industry.
Alla Shifrin, MD (Rambam Medical Center)	Dr. Shifrin has nothing to disclose.
Ronit Gilad	Ms. Gilad has nothing to disclose.
	No disclosure on file
Dimitrios Karussis, MD, PhD (Hadassah HMO)	Prof. Karussis has nothing to disclose.
Arnon Karni, MD, PhD (Tel Aviv Sourasky medical center)	Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Prof. Karni has received research support from Medison. The institution of Prof. Karni has received research support from BMS. The institution of Prof. Karni has received research support from Novartis.

��ɫ��

��ɫ��