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.
“As we near the end of 2015, Alkermes is aggressively executing on our strategy to build a leading biopharmaceutical company for CNS innovation, characterized by one of the most exciting late-stage CNS pipelines in the industry,” said Richard Pops, chief executive officer of Alkermes, in a press release. “This is a particularly productive time in the company’s history, and looking ahead to 2016, we expect significant value-creating milestones as we continue to advance our late-stage pipeline and grow our commercial products.”
“We are pleased with the rapid progress of our late-stage pipeline, with … ALKS 3831 and ALKS 8700 entering registration trials,” added Dr. Elliot Ehrich, the company’s chief medical officer. “We have successfully hit the key milestones we set out to achieve in 2015.”
Alkermes plans to submit a New Drug Application (NDA) for ALKS 8700 to the FDA in 2018.