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Monday, October 3, 2016

Phase 3 Study to Test Oral Combination, Tecfidera and Ponesimod, to Treat Relapsing MS


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Actelion announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod and Tecfidera (dimethyl fumarate) as a treatment for relapsing multiple sclerosis (RMS).
The Phase 3 clinical study, being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find a combination treatment that has greater efficacy and superior safety, so as to minimize side effects, as a long-term therapy. Preclinical data suggest that the combination of Ponesimod and dimethyl fumarate meets both these requirements.
“I have always believed that combination therapy is the future for the treatment of relapsing multiple sclerosis. The properties of Ponesimod, supported by our pre-clinical knowledge and clinical results, all point towards Ponesimod being ideally suited for use in combination. I am very excited that we’ve gained agreement with health authorities on this innovative approach, and I look forward to Actelion generating the data that could change the treatment paradigm in this devastating disorder,” Jean-Paul Clozel, MD, Actelion’s chief executive officer, said in a press release.
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