Date: 2015-12-16
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Alkermes (Ireland)
Product: ALKS 8700 (monomethyl fumarate)
Action
mechanism: dicarboxylic acid. ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, Tecfidera®.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: USA
Trial
details: This phase 3 open label study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of relapsing remitting multiple sclerosis. (NCT02634307)
Latest
news: * On December 16, 2015, Alkermes announced the initiation of the EVOLVE pivotal program for ALKS 8700: EVOLVE-1, a two-year, multicenter, open-label study to assess the safety of ALKS 8700 in approximately 600 patients with MS, is now underway and enrolling patients. This is the first study to initiate from the EVOLVE (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) pivotal program of ALKS 8700 for the treatment of multiple sclerosis. Alkermes plans to include data from EVOLVE-1, as well as pharmacokinetic bridging data from studies comparing ALKS 8700 and Tecfidera®, to support registration of ALKS 8700, based on feedback from the FDA . In addition, Alkermes intends to initiate EVOLVE-2, a randomized, head-to-head study comparing the gastrointestinal tolerability of ALKS 8700 and Tecfidera® in up to 420 patients with MS, in mid-2016. Alkermes plans to submit the NDA for ALKS 8700 to the FDA in 2018.
