ECTRIMS: Alkermes Demontrates Safety and GI Tolerability of Investigational Oral Agent for Relapsing MS
Alkermes presented safety and gastrointestinal (GI) tolerability data from EVOLVE-MS-1, an ongoing open-label, two-year phase 3 safety study for ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing multiple sclerosis (MS) at Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in Paris.
The study included more than 570 patients at one and three months of treatment with ALKS 8700, in which safety data from the first month showed that treatment with ALKS 8700 was associated with low rates of GI adverse events (AEs) leading to discontinuation (0.5%) and no occurrence of serious GI AEs. The most common AEs during the first month of treatment with ALKS 8700 were flushing (31.7%), pruritus (7.4%) and diarrhea (6.6%). Data from the initial three months of treatment in the study support and extend the safety profile for ALKS 8700, with 2.3% of patients reporting serious AEs, and 3.7% experiencing AEs that led to study discontinuation.
The company expects to unveil additional data in early 2018 comparing 8700 to dimethyl fumurate (Tecfidera, Biogen).