Diroximel fumarate superior to Tecfidera for gastrointestinal tolerability on EVOLVE-MS-2 study�s primary endpoint

Alkermes plc and Biogen Inc. announced positive topline results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase III study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis (RRMS), compared to Tecfidera (dimethyl fumarate).

Diroximel fumarate was statistically superior to dimethyl fumarate on the study’s pre-specified primary endpoint, with patients treated with diroximel fumarate self-reporting significantly fewer days of key gastrointestinal (GI) symptoms with intensity scoresgreater than 2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS), as compared to dimethyl fumarate (p=0.0003). The most common adverse events (AEs) reported in the study for both treatment groups were flushing, diarrhea and nausea (32.8%, 15.4% and 14.6% for diroximel fumarate; 40.6%, 22.3% and 20.7% for dimethyl fumarate). The overall proportion of patients with AEs leading to study discontinuation were 1.6% for diroximel fumarate and 6.0% for dimethyl fumarate. Of those, the proportion of patients who discontinued due to GI adverse events during the five-week treatment period were 0.8% for diroximel fumarate and 4.8% for dimethyl fumarate. Further analysis of the data from the EVOLVE-MS-2 study is ongoing and will be presented at a future scientific forum.