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ARTICLE | Clinical News

Pfizer ends Phase II trials of DMD candidate

August 31, 2018 7:43 PM UTC

Pfizer Inc. (NYSE:PFE) terminated two Phase II trials of domagrozumab (PF-06252616) to treat Duchenne muscular dystrophy after one of the studies missed its primary endpoint. The company will evaluate the data to determine next steps for the humanized mAb against myostatin (MSTN; GDF8), which it had believed was a potential blockbuster.

In the double-blind, international Phase II B5161002 trial evaluating safety and efficacy, domagrozumab showed no significant improvement compared with placebo on the mean change from baseline to one year on a four-stair climb test, missing its primary endpoint. Pfizer said evaluation of all available data, including secondary endpoint results, did not suggest a significant treatment effect. The trial enrolled 121 boys ages 6-15 with DMD, irrespective of underlying mutations, to receive placebo or once-monthly IV domagrozumab plus background corticosteroids...

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