Pharvaris announces FDA lifting of the clinical hold of deucrictibant for the prophylactic treatment of HAE attacks
Pharvaris today announces that the US 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.
Berndt Modig, Chief Executive Officer of Pharvaris, said: “The lift of the clinical hold in the US enables us to progress the global development of deucrictibant for long-term prophylaxis, including resuming the open-label portion of CHAPTER-1, our Phase 2 proof-of-concept study of deucrictibant for the prevention of HAE attacks, in the US.
“We are pleased to have worked collaboratively with the FDA to address the requests of the agency with the submission of additional nonclinical data, and we appreciate the agency’s comments and recommendations regarding study conduct. We will request an End-of-Phase 2 meeting with the FDA to align on key elements of CHAPTER-3, the anticipated global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks.”
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 US, and the regulatory status of deucrictibant outside the US 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 US following FDA review of data from a pre-planned 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.
(Source: Pharvaris)
