Business
Pharvaris Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Highlights
Phase 1 pharmacokinetics study demonstrates PHVS719 well tolerated with extended-release profile supporting once-daily dosingOrphan Drug Designation for
About this update from Pharvaris N.v.
[{"type":"text","content":"Phase 1 pharmacokinetics study demonstrates PHVS719 well tolerated with extended-release profile supporting once-daily dosingOrphan Drug Designation for PHA121 granted by FDARAPIDe-1, Phase 2 on-demand study of PHVS416 for the treatment of HAE attacks ongoing; top-line data anticipated in 4Q22CHAPTER-1, Phase 2 prophylactic study of PHVS416 for the prevention of HAE attacks trial enrolling patients; top-line data anticipated in 4Q22Executing from a strong financial position with cash and cash equivalents balance of €209.4 million as of December 31, 2021; runway expected into 1Q24 ZUG, Switzerland, March 29, 2022 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks, building on its deep-seated roots in hereditary angioedema (HAE), today reported financial results for the fourth quarter and year ended December 31, 2021 and provided recent business highlights. “The time since our initial public offering in February 2021 has been transformational for Pharvaris, enabling us to reach clinical development milestones, including initiation and continued progress of our Phase 2 RAPIDe-1 on-demand study of PHVS416, the initiation and enrollment of our Phase 2 CHAPTER-1 prophylactic study of PHVS416, and the completion of our Phase 1 pharmacokinetics study for PHVS719,” said Berndt Modig, chief executive officer of Pharvaris. “We look forward to our next milestones, including announcing top-line data from our Phase 2 trials, RAPIDe-1 and CHAPTER-1. We will continue to execute our strategy efficiently in 2022 supporting our mission to provide individual choice for managing HAE through potent and convenient oral on-demand and prophylactic therapies.” Recent Business Highlights and UpdatesPipeline Top-line Phase 1 data demonstrate extended-release PHVS719 suitable for once-daily dosing. The Phase 1 pharmacokinetics (PK) study of PHVS719 included 8 healthy volunteers dosed in an open-label randomized five-period crossover single-dose study to assess bioavailability of two different extended-release formulations with and without food, in comparison to a single dose of PHVS416 without food. The pharmacokinetics of a single dose of PHVS719 (40 mg) under fasted conditions yielded exposure above 13.8 ng/mL (the EC85 determined in a Phase 1 br...