Pharvaris: FDA Removes Clinical Hold of Deucrictibant for Treatment of HAE
26 June 2023 - 9:39PM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
June 26, 2023 07:24 ET (11:24 GMT)
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