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Zafgen reports patient death

October 15, 2015 12:59 AM UTC

Zafgen Inc. (NASDAQ:ZFGN) said a patient died of an unknown cause in the Phase III bestPWS trial of beloranib ( ZGN-440) to treat Prader-Willi syndrome. The company said it is working with FDA to review and understand the event and determine how it will affect the trial. Zafgen said it will provide an update as those discussions progress.

Zafgen CFO Patricia Allen told BioCentury that Zafgen's management is blinded as to whether the patient who died received beloranib or placebo in the study. The randomized, double-blind trial includes treatment arms of 1.8 mg and 2.4 mg beloranib twice weekly and one placebo arm. ...