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MS Pipeline Drug: ALKS 8700

March 20, 2017

Alkermes has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS).

The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera (dimethyl fumarate). The 420 patients with relapsing-remitting MS (RRMS) will receive either 462 mg of ALKS 8700 twice a day or 240 mg of Tecfidera.

A prodrug is a compound the body converts into an active therapy. U.S. regulators have already approved Tecfidera, while ALKS 8700 is still in the treatment-candidate stage.

“ALKS 8700, a MMF prodrug with distinct physical-chemical properties, is designed to provide therapeutic concentrations of MMF in the body and offer differentiated features as compared to the market leader, dimethyl fumarate, TECFIDERA, which is associated with gastrointestinal side effects. These adverse events can lead to treatment interruption or discontinuation for patients with MS,” Elliot Ehrich, MD, Alkermes’ chief medical officer, said in a press release.

“We believe ALKS 8700 may represent a valuable new option for patients suffering from MS who want the efficacy of fumarate therapy with more favorable gastrointestinal tolerability,” Ehrich added.