Pharvaris declared that the U.S. Food and Drug Administration (FDA) has withdrawn clinical hold on the Investigational New Drug (IND) application for deucrictibant in the on-demand treatment of hereditary angioedema (HAE).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.