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. It is immunomodulatory in nature and thought to possess anti-oxidant properties that help to protect the myelin sheath that insulates nerve fibers and to do so without leading to immune suppression.
ALKS 8700 and clinical trials
A Phase 1, randomized and double-blind study (NCT02201849), conducted in 2015, assessed the safety, tolerability and pharmacokinetics of a single dose of either ALKS 8700 or Tecfidera in 35 healthy participants. The treatment was then changed to enable crossover comparison. Results showed that ALKS 8700 met the standards for being a bioequivalent therapy to Tecfidera. The most common adverse effects were flushing, dizziness, and constipation for ALKS 8700, and flushing, nausea, and diarrhea for Tecfidera.
A Phase 3 clinical trial, called EVOLVE MS (NCT02634307), is now evaluating the long-term safety and tolerability of ALKS 8700 in an estimated 800 people with relapsing MS. The study, which is recruiting patients at more than 100 sites across the U.S. and Europe, will measure safety via adverse events recorded over its 96 weeks. It is expected to end in December 2020.
The EVOLVE-MS clinical development program also includes an elective head-to-head study comparing the gastrointestinal tolerability of ALKS 8700, at 462 mg twice daily, and Tecfidera at 240 mg twice daily. This is a five-week study involving some 420 people with relapsing MS. Common gastrointestinal symptoms, including nausea, vomiting, upper and lower abdominal pain and diarrhea, will be evaluated using two patient-reported symptom rating scales: the Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and the Global Gastrointestinal Symptom and Impact Scale (GGISIS). The intensity, frequency and duration of these symptoms, as well as their impact on daily life, will also be assessed.
Alkermes is planning to file a New Drug Application for ALKS 8700 with the FDA in 2018.
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