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Saturday, December 19, 2015

Alkermes enrolling MS patients to assess safety of ALKS 8700 (MMF) compared to Tecfidera

New MS Drug Therapy Based on Monomethyl Fumarate 
Moving Along in Testing

Dec 18, 2015

Alkermes plc, a biopharmaceutical company focused on therapies for the treatment of central nervous system (CNS) disorders, announced that it has successfully met its 2015 goals for their product and late-stage pipeline drug portfolio, including ALKS 8700, a monomethyl fumarate (MMF) drug candidate for the treatment of multiple sclerosis (MS).
Alkermes launched pivotal clinical development programs for two of its pipeline drugs: ALKS 8700, a new, oral MMF drug for MS treatment, and ALKS 3831, a new, oral atypical antipsychotic drug for the treatment of schizophrenia.
MMF is thought to have immunomodulatory and anti-inflammatory properties, although its mechanism of action is still not clear. ALKS 8700 is a drug designed to quickly and efficiently convert to MMF inside the patient’s body, offering distinct features from the marketed MS therapy dimethyl fumarate (Tecfidera).
ALKS 8700 pivotal program EVOLVE (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) comprises two studies. EVOLVE-1 is a multicenter, two-year, open-label trial to evaluate ALKS 8700 safety in 600 MS patients. This ongoing study is currently enrolling participants. Alkermes is planning to register ALKS 8700 based on data from EVOLVE-1, and on pharmacokinetic bridging results from studies where ALKS 8700 was compared to Tecfidera, and feedback obtained from the U.S Food and Drug Administration (FDA). The company also plans to conduct a second randomized, head-to-head study (EVOLVE-2) in 2016 to compare the gastrointestinal tolerability of ALKS 8700 to Tecfidera in up to 420 MS patients.
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