FDA Removes Clinical Hold Of Pharvaris' Deucrictibant For On-Demand Treatment Of HAE

Pharvaris NV PHVS announced that the FDA lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant (PHA-121) for the on-demand treatment of hereditary angioedema (HAE).

This decision came after reviewing data from a preplanned interim analysis of the ongoing 26-week nonclinical study.

Pharvaris expects to submit data from this 26-week nonclinical study by the end of 2023, addressing the remaining hold on the IND application for deucrictibant prophylactic HAE treatment.

In August last year, the FDA placed clinical studies of PHA121, including RAPIDe-1 and CHAPTER-1, on hold. 

The FDA has agreed to partially lift the hold on on-demand to allow the two remaining U.S. participants in RAPIDe-1 to complete treatment of the last attack per the protocol.

Topline data from RAPIDe-1 was announced in December 2022.

The lift of the clinical hold allows Pharvaris to resume RAPIDe-2, their extension study for acute treatment of attacks in the U.S.

The company also plans to request an end-of-Phase 2 meeting with the FDA and is preparing for RAPIDe-3, their global Phase 3 study of PHVS416 for the on-demand treatment of HAE, to include U.S. sites.

The 26-week nonclinical study addressing the remaining hold on prophylactic deucrictibant in the U.S. is still in progress, with the data from this study planned for submission to the FDA by the end of the year.

Pharvaris confirms that top-line data from CHAPTER-1, their Phase 2 proof-of-concept study of PHVS416 for the prophylactic treatment of HAE, remains on track to be announced by the end of the year, based on current enrollment.

Price Action: PHVS shares are up 14.70% at $13.31 on the last check Monday.