The FDA lifted the clinical hold on Pharvaris’ (NASDAQ:PHVS) IND application for deucrictibant for the on-demand treatment of hereditary angioedema (HAE) following a review of data from a preplanned interim analysis of the ongoing 26-week nonclinical study.
Pharvaris 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,” Peng Lu, M.D., Ph.D., CMO of Pharvaris, said in a statement.
“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 U.S. sites,” Dr. Lu added.
Based on current enrollment, the company confirmed that top-line data from CHAPTER-1, 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.
