Pharvaris provides business updates and company highlights:
- Meeting minutes from Type A meeting with U.S. Food and Drug Administration (FDA) received. Pharvaris will conduct a 26-week rodent toxicology study to resolve the clinical holds in the U.S. The protocol for this nonclinical study has been submitted to the FDA for review.
- FDA approval of dosing of final U.S. participants in RAPIDe-1 received. The FDA has agreed to partially lift the hold on on-demand to allow the two remaining U.S. participants in RAPIDe-1 to complete treatment of the last attack per the protocol. Positive top-line data from RAPIDe-1 was announced in December 2022. RAPIDe-2, a long-term extension study of PHVS416 for the on-demand treatment of HAE, is currently on hold in the U.S. and is underway outside the U.S.
- Top-line data from CHAPTER-1, a global Phase 2 study of PHVS416 for the prophylactic treatment of HAE attacks, anticipated 2H2023. CHAPTER-1 is currently on hold in the U.S. All active sites outside of the U.S. continue to recruit participants in the CHAPTER-1 clinical study. After being notified of the clinical holds in the U.S. by the FDA, Pharvaris informed country-specific regulatory authorities in Canada, Europe, Israel, and the UK regarding the clinical holds in the U.S. To date, the regulatory status of the CHAPTER-1 study outside the U.S. remains unchanged. Based on the Company’s current assumptions regarding ex-U.S. regulatory status and enrollment, Pharvaris anticipates announcing top-line data from the CHAPTER-1 trial in 2H2023.
(Source: Pharvaris)
