Alkermes to Present Clinical Data on ALKS 8700 at Annual Meeting of the Consortium of Multiple Sclerosis Centers

Alkermes plc

today announced that data from its phase 1, randomized, double-blind clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS), is scheduled to be presented at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) being held in Indianapolis, Ind., May 27-30, 2015. ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA®. The study evaluated the safety, tolerability and single-dose pharmacokinetics (PK) of oral formulations of ALKS 8700 compared to both placebo and active control groups in healthy volunteers. Data from the study showed that ALKS 8700 was generally well tolerated and provided MMF exposures comparable to TECFIDERA, with less variability and favorable gastrointestinal (GI) tolerability. The most common adverse events (AEs) were flushing and GI-related. Based on the positive results from the study, Alkermes plans to advance ALKS 8700 with twice-daily dosing into pivotal development in 2015. "The data being presented during the CMSC annual meeting demonstrated that ALKS 8700 efficiently converts to MMF following oral administration with the potential to offer favorable GI tolerability for patients with MS," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We are committed to bringing this innovative potential new treatment option to patients and remain on track to initiate pivotal development of ALKS 8700 later this year." A poster on the phase 1 data, titled "Safety, Tolerability and Pharmacokinetics of ALKS 8700, a Novel Oral Therapy for Relapsing-Remitting Multiple Sclerosis in Healthy Subjects" (P# DX37) will be presented on Friday, May 29, 2015, 12:00 – 2:00 p.m. EDT. For more information including a complete list of abstract titles, please visit the CMSC website at http://annualmeeting.mscare.org.