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#Post#: 1045-------------------------------------------------- |
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New MS drug therapy based on monomethyl fumarate being tested |
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By: agate Date: December 24, 2015, 10:54 pm |
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From Multiple Sclerosis News Today, December 24, 2015: |
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[quote]New MS Drug Therapy Based on Monomethyl Fumarate Moving |
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Along in Testing |
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Alkermes enrolling MS patients to assess safety of ALKS 8700 |
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(MMF) compared to Tecfidera |
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Patricia Silva, PhD |
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Alkermes plc, a biopharmaceutical company focused on therapies |
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for the treatment of central nervous system (CNS) disorders, |
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announced that it has successfully met its 2015 goals for their |
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product and late-stage pipeline drug portfolio, including ALKS |
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8700, a monomethyl fumarate (MMF) drug candidate for the |
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treatment of multiple sclerosis (MS). |
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Alkermes launched pivotal clinical development programs for two |
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of its pipeline drugs: ALKS 8700, a new, oral MMF drug for MS |
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treatment, and ALKS 3831, a new, oral atypical antipsychotic |
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drug for the treatment of schizophrenia. |
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MMF is thought to have immunomodulatory and anti-inflammatory |
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properties, although its mechanism of action is still not clear. |
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ALKS 8700 is a drug designed to quickly and efficiently convert |
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to MMF inside the patient�s body, offering distinct features |
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from the marketed MS therapy dimethyl fumarate (Tecfidera). |
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ALKS 8700 pivotal program EVOLVE (Endeavoring to Advance |
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Treatment for Patients Living with Multiple Sclerosis) comprises |
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two studies. EVOLVE-1 is a multicenter, two-year, open-label |
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trial to evaluate ALKS 8700 safety in 600 MS patients. This |
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ongoing study is currently enrolling participants. Alkermes is |
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planning to register ALKS 8700 based on data from EVOLVE-1, and |
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on pharmacokinetic bridging results from studies where ALKS 8700 |
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was compared to Tecfidera, and feedback obtained from the U.S |
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Food and Drug Administration (FDA). The company also plans to |
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conduct a second randomized, head-to-head study (EVOLVE-2) in |
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2016 to compare the gastrointestinal tolerability of ALKS 8700 |
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to Tecfidera in up to 420 MS patients. |
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�As we near the end of 2015, Alkermes is aggressively executing |
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on our strategy to build a leading biopharmaceutical company for |
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CNS innovation, characterized by one of the most exciting |
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late-stage CNS pipelines in the industry,� said Richard Pops, |
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chief executive officer of Alkermes, in a press release. �This |
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is a particularly productive time in the company�s history, and |
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looking ahead to 2016, we expect significant value-creating |
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milestones as we continue to advance our late-stage pipeline and |
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grow our commercial products.� |
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�We are pleased with the rapid progress of our late-stage |
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pipeline, with � ALKS 3831 and ALKS 8700 entering registration |
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trials,� added Dr. Elliot Ehrich, the company�s chief medical |
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officer. �We have successfully hit the key milestones we set out |
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to achieve in 2015.� |
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Alkermes plans to submit a New Drug Application (NDA) for ALKS |
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8700 to the FDA in 2018.[/quote] |
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