Abstract Details

Title MRI and Relapse Results for ALKS 8700 in Patients with Relapsing Remitting Multiple Sclerosis: 1-year Interim Results from the Phase 3 EVOLVE-MS-1 Study

Topic

Presentation(s) ES1 - (-)

Poster/Presentation
Number 006

Objective

Background ALKS 8700 is a prodrug of monomethyl fumarate (MMF), the active metabolite of dimethyl fumarate (DMF). DMF is approved for relapsing forms of multiple sclerosis (RMS). ALKS 8700 is being developed as an oral disease-modifying therapy for RMS and is designed to treat MS with the same active metabolite as DMF but with potentially improved gastrointestinal tolerability. Two Phase 3 studies are currently evaluating ALKS 8700 in patients with RRMS: EVOLVE-MS-1, a long-term safety and tolerability study of ALKS 8700, and EVOLVE-MS-2, a 5-week, head-to-head study comparing the gastrointestinal tolerability of ALKS 8700 and DMF.

Design/Methods EVOLVE-MS-1 is a multi-center, prospective, open-label, single-arm Phase 3 study to assess long-term safety, tolerability, and treatment effect of ALKS 8700 462 mg twice daily in approximately 900 patients with RRMS. Inclusion criteria: age 18–65 years with RRMS (McDonald criteria 2010) and EDSS ?6.0. We present an exploratory interim report from November 2017 of annualized relapse rate (ARR) and MRI parameters.

Results ARR was 0.16 for the 570 patients (493.6 patient-years) evaluated during this interim analysis. Interim MRI results included 152 patients who completed MRI assessments at 1 year. Mean numbers (SD) of new/enlarging T2 lesions, gadolinium-enhancing (Gd+) lesions, and new T1-hypointense lesions were 2.8 (5.9), 0.3 (1.1), and 1.8 (4.2), respectively. With ALKS 8700 treatment there was a significant reduction (p<0.0001) in the number of Gd+ lesions from baseline (mean 1.2 [SD 4.1]) to 1 year (0.3 [1.1]).

Conclusions ALKS 8700 is a novel, oral, prodrug of MMF in Phase 3 development for the treatment of RRMS. These preliminary findings suggest ALKS 8700 may be an effective oral treatment option for patients with RRMS.

Authors/Disclosures
Richard Leigh-Pemberton, MD (Alkermes)	No disclosure on file
Robert T. Naismith, MD, FAAN (Washington University)	Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squib. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Naismith has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genzyme. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celltrion. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impaact-Bio. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Journal Watch.
Boris Kandinov	No disclosure on file
David Rezendes	No disclosure on file
	No disclosure on file
Maria V. Lopez-Bresnahan, MD, FAAN	No disclosure on file
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has stock in NeuroRx.
Jerry S. Wolinsky, MD, FAAN (McGovern Medical School, UTHealth)	Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cleveland Clinic Foundation. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inmagene. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis/Sandoz. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Alabama Birmingham. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care.

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