Pfizer CIFFREO Phase 3 ambulatory trial re-started

Pfizer is pleased to share the good news that several regulatory authorities have approved the re-start of their Phase 3 ambulatory trial (CIFFREO) for the investigational mini-dystrophin gene therapy for Duchenne muscular dystrophy.

The U.S. FDA notified Pfizer that the clinical hold has been lifted and and that Pfizer has addressed the agency’s requests related to the potency assay. As such, Pfizer may proceed with the study in the United States. This means that they are now working to activate U.S. trial sites to begin recruitment, screening, and enrollment in CIFFREO for the first time.

Read the full community letter here.