Pharvaris Announces FDA Removal of Clinical Hold of Deucrictibant for the On-Demand Treatment of HAE

ZUG, Switzerland, June 26, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the on-demand treatment of HAE following 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,” said Peng Lu, M.D., Ph.D., 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 U.S. sites. The 26-week nonclinical study to address the remaining hold on prophylactic deucrictibant in the U.S. 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.”

About Pharvaris
Building on its deep-seated roots in hereditary angioedema (HAE), Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks. By directly targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE safe, effective, and convenient alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.