FDA puts clinical hold on Zafgen' beloranib trials

US biotech firm Zafgen (Nasdaq: ZFGN) has received verbal notice from the US Food and Drug Administration that beloranib has been placed on partial clinical hold.

This partial clinical hold impacts ongoing or planned clinical trials, including ZAF-311 and ZAF-312. A partial clinical hold is an order that the FDA issues to delay or suspend part of a sponsor’s clinical work requested under its Investigational New Drug application.

As previously reported (The Pharma Letter October 15), Zafgen learned of a death in the ongoing Phase III bestPWS study (ZAF-311) of beloranib in Prader-Willi syndrome (PWS). While the cause of death remains unknown, the patient’s treatment assignment has been unblinded and it is now known that the patient was receiving beloranib.