Pharvaris Says FDA Lifts Clinical Hold On IND For Deucrictibant For Treatment Of HAE Attacks

(RTTNews) - Clinical-stage company Pharvaris N.V. (PHVS) announced Monday the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the prophylactic treatment of HAE attacks following review of data from a 26-week rodent toxicology study.

The company noted that the lift of the clinical hold in the U.S. enables it to progress the global development of deucrictibant for long-term prophylaxis, including resuming the open-label portion of CHAPTER-1, its Phase 2 proof-of-concept study of deucrictibant for the prevention of HAE attacks, in the U.S.

In August 2022, the FDA placed clinical studies of deucrictibant, including CHAPTER-1, on hold. Pharvaris notified ex-U.S. country-specific regulatory authorities of the clinical hold in the U.S., and the regulatory status of deucrictibant outside the U.S. was not affected.