The US Food and Drug Administration (FDA) has removed its clinical hold on the Investigational New Drug (IND) application for deucrictibant, an oral bradykinin-B2 receptor antagonist being developed by Pharvaris to treat and prevent hereditary angioedema (HAE) attacks.
This positive development comes after a thorough evaluation of data from a preplanned interim analysis of the ongoing 26-week nonclinical study.
“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 US, including resuming RAPIDe-2, our extension study for acute treatment of attacks,” said Peng Lu, MD, PhD, chief medical officer of Pharvaris.
“Our team plans to request an end of Phase 2 meeting with the agency and is preparing for RAPIDe-3, our global Phase 3 study of PHVS416 for the on-demand treatment of HAE, to include US sites. The 26-week nonclinical study to address the remaining hold on prophylactic deucrictibant in the US is still progressing and we plan to submit the data from that study to the FDA by the end of the year. Based on current enrollment, we confirm that top-line data from CHAPTER-1, our 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.”
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Pharvaris plans to submit the data from the 26-week nonclinical study by the end of 2023 to address the remaining hold on the IND application for deucrictibant as a prophylactic treatment for HAE.
The company has recently presented positive results from the RAPID-e1 phase 2 study of deucrictibant for the on-demand treatment of HAE attacks at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023.
Pharvaris announces FDA removal of clinical hold of deucrictibant for the on-demand treatment of HAE. News release. Pharvaris; June 26, 2023.