FDA Lifts Clinical Hold on Deucrictibant for HAE Treatment

Pharvaris declared that the U.S. Food and Drug Administration (FDA) has withdrawn clinical hold on the Investigational New Drug (IND) application for deucrictibant in the on-demand treatment of hereditary angioedema (HAE). This was following review of data collected from a preplanned interim analysis in an ongoing 26-week nonclinical study.

Peng Lu, Pharvaris’ chief medical officer, conveyed that lifting the clinical hold will enable the company to resume PHVS416 deucrictibant immediate-release capsules development in the U.S. This encompasses continuing the RAPIDe-2 extension study for acute treatment of HAE attacks.

Pharvaris says that top-line data from its Phase 2 proof-of-concept study of PHVS416 for the prophylactic treatment of HAE remains on schedule to be disseminated before this year ends. The company expects to submit data from the 26-week nonclinical study addressing the remaining hold on IND application for prophylactic treatment of HAE by the end of 2023.

Pharvaris disclosed it intends to request an end-of-Phase 2 meeting with the FDA and is getting ready for a worldwide Phase 3 study of PHVS416, involving U.S. locations, for HAE on-demand treatment.

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