FDA puts trial of ZGN 433 (beloranib) in patients with Prader-Willi syndrome on hold- Zafgen

Zafgen has received verbal notice from the FDA that its ZGN 433 (beloranib) investigational new drug (IND) application in patients with Prader-Willi syndrome (PWS) has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal Phase III ZAF-311 bestPWS clinical trial. A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the Company’s IND application. This follows a second death reported during the trial.