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ARTICLE | Clinical News

Merck's bezlotoxumab meets in two Phase III trials

September 22, 2015 3:58 AM UTC

Merck & Co. Inc. (NYSE:MRK) said bezlotoxumab ( MDX-1388) met the primary endpoint in two Phase III trials to treat Clostridium difficile infection recurrence. The company said bezlotoxumab alone and in combination with actoxumab ( MDX-066) significantly reduced the rate of infection recurrence over placebo in the Phase III MODIFY I and MODIFY II trials.

Merck plans to seek regulatory approval for bezlotoxumab in the U.S., EU and Canada this year. The company said the combination of bezlotoxumab and actoxumab did not improve efficacy over bezlotoxumab alone, and actoxumab alone did not improve infection recurrence compared with placebo. In MODIFY I, Merck said a treatment arm with actoxumab alone was stopped "for efficacy and safety reasons" following an interim analysis. Merck did not respond to inquiries. ...