Pharvaris: FDA Removes Clinical Hold of Deucrictibant for Treatment of HAE

By Chris Wack

Pharvaris said Monday that the U.S. Food and Drug Administration has lifted the clinical hold on the Investigational New Drug application for deucrictibant for the on-demand treatment of hereditary angioedema following review of data from a preplanned interim analysis of the ongoing 26-week nonclinical study.

The company said it expects to submit data from the 26-week nonclinical study by the end of 2023 to address the remaining hold on the IND application for deucrictibant for prophylactic treatment of HAE.

"The lift of the clinical hold on our on-demand clinical trials enables us to continue development of PHVS416 deucrictibant immediate-release capsules in the U.S., including resuming RAPIDe-2, our extension study for acute treatment of attacks," said Peng Lu, chief medical officer of Pharvaris.

The company said it plans to request an end of Phase 2 meeting with the FDA and is preparing for its global Phase 3 study of PHVS416 for the on-demand treatment of HAE to include U.S. sites. Based on current enrollment, top-line data from its 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.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

June 26, 2023 07:24 ET (11:24 GMT)

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