Alkremes Inc. is developing a new oral formulation, ALKS 8700, to treat multiple sclerosis (MS), a demyelinating neurodegenerative disorder of the central nervous system.
How ALKS 8700 Works
ALKS 8700 is a monomethyl fumarate (MMF) molecule that the company believes can perform better than dimethyl fumarate (Tecfidera, marketed by Biogen), a U.S. Food and Drug Administration-approved oral therapy for relapsing forms of MS.
The mechanism of action for ALKS 8700 is not clearly understood, but it is known to rapidly convert to MMF in the body after administration. It is immunomodulatory in nature and is thought to possess anti-oxidant properties that help in protecting the myelin sheath covering nerve fibers without leading to immune suppression.
History of ALKS 8700
Owing to successful pre-clinical data, a Phase I, randomized, double-blind study to assess the safety, tolerability and pharmacokinetics of the drug in 35 healthy participants was conducted by Alkremes. Participants, ages 18 and 55, were given a single dose of either ALKS 8700 or Tecfidera, followed by the other agent in a subsequent treatment period to enable crossover comparison. Initial data, reported in October 2015, showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to Tecfidera. The most common adverse effects were flushing, dizziness, and constipation for ALKS 8700, and flushing, nausea, and diarrhea for Tecfidera.
Next Steps for ALKS 8700
A Phase 3 clinical trial, called EVOLVE MS, evaluating the long-term safety and efficacy of ALKS 8700 in an estimated 600 people with relapsing MS, is now underway and recruiting participants. Alkermes also plans to initiate a randomized, head-to-head study comparing the gastrointestinal tolerability of ALKS 8700 and Tecfidera in about 420 MS patients in mid-2016. Upon successful completion of these studies, the company expects to file a New Drug Application for ALKS 8700 with the FDA in 2018.
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