Second Patient Dies in Zafgen’s Beloranib Trial

December 8, 2015

A second patient receiving Zafgen’s beloranib has died after being diagnosed with bilateral pulmonary emboli.

Zafgen CEO Thomas Hughes says the company is investigating the circumstances around the event and is in discussions with the FDA to determine next steps for its clinical program for the methionine aminopeptidase 2 inhibitor. Beloranib is being studied for the treatment of Prader-Willi syndrome, which can lead to obesity.

In October, the FDA placed a partial hold on the Phase 3 trial after news of an earlier patient death. Zafgen reported that the cause of death was respiratory failure from pulmonary emboli, and at the time the drugmaker said the connection between the death and beloranib remained unknown. The Boston drugmaker announced its intentions to continue with the trial a few days later.