Alkermes Presents Data Demonstrating Safety and Gastrointestinal Tolerability Profile of ALKS 8700 for the Treatment of Multiple Sclerosis

Alkermes plc (NASDAQ: ALKS) today 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 forms of multiple sclerosis (MS). Interim data from more than 570 patients at one and three months of treatment with ALKS 8700 were presented at MSParis2017, the 7^th 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, France.

Safety data from the first month of the EVOLVE-MS-1 study (N=580) 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 (N=574) 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.

“When choosing a treatment regimen for a chronic disease like MS, patients and their healthcare providers must weigh multiple factors, including efficacy, safety, tolerability and convenience. Fumarate therapy is recognized in the clinical community as an efficacious option for patients with MS, but it is also known to be associated with GI side effects that may lead to treatment interruption or discontinuation, particularly in the first few weeks following treatment initiation,” said Robert Naismith, M.D., Associate Professor of Neurology, Washington University School of Medicine in St. Louis. “A new treatment option that provides therapeutic levels of fumarate therapy with a differentiated safety profile would be a valuable and welcomed option for members of the MS community.”

“We are encouraged by the safety data presented today for ALKS 8700, a MMF prodrug with distinct physical-chemical properties, as these interim results reinforce the safety and GI tolerability profile we set out to develop in a potential new oral therapy for the treatment of MS,” said Elliot Ehrich, M.D., Executive Vice President of Research and Development at Alkermes. “We are committed to bringing this potential valuable new treatment to patients and providers and remain on track to announce initial data from the GI tolerability study comparing ALKS 8700 to TECFIDERA, and to submit the planned New Drug Application for ALKS 8700 in 2018.”