Alkermes has initiated a new phase 3 study of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis.
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 phase 3, multicentre, double-blind, active-controlled, five-week, head-to-head study will evaluate is designed to evaluate the GI tolerability of ALKS 8700 462 mg twice daily compared to TECFIDERA 240 mg twice daily in approximately 420 patients with relapsing-remitting multiple sclerosis (RRMS). Key GI symptoms, including nausea, vomiting, upper and lower abdominal pain and diarrhoea, will be assessed using two patient-reported symptom rating scales: the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and the Global Gastrointestinal Symptom and Impact Scale (GGISIS). Intensity, frequency and duration of symptoms, as well as effect on daily activities will also be assessed.
This elective study is part of the ongoing clinical development program for ALKS 8700, named EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis). The company plans to submit a New Drug Application (NDA) for ALKS 8700 for the treatment of RRMS to the US Food and Drug Administration (FDA) in 2018.