Pharvaris announces FDA lifting of clinical hold of deucrictibant in HAE attacks

Pharvaris announced the FDA has lifted the clinical hold on the Investigational New Drug application for deucrictibant for the prophylactic treatment of hereditary angioedema, or HAE, attacks following review of data from a 26-week rodent toxicology study. 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. In June 2023, Pharvaris announced the FDA’s removal of the clinical hold of deucrictibant for the on-demand treatment of HAE in the U.S. following FDA review of data from a preplanned interim analysis of a 26-week rodent toxicology study. In December 2023, Pharvaris announced positive top-line clinical data from the Phase 2 CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks.