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       #Post#: 1045--------------------------------------------------
       New MS drug therapy based on monomethyl fumarate being tested
       By: agate Date: December 24, 2015, 10:54 pm
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       From Multiple Sclerosis News Today, December 24, 2015:
       [quote]New MS Drug Therapy Based on Monomethyl Fumarate Moving
       Along in Testing
       Alkermes enrolling MS patients to assess safety of ALKS 8700
       (MMF) compared to Tecfidera
       Patricia Silva, PhD
       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.[/quote]
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