Business
Pharvaris Reports First Quarter 2023 Financial Results and Provides Business Update
Top-line data from CHAPTER-1, a proof-of-concept Phase 2 study of PHVS416 (immediate-release deucrictibant capsules) for the prophylactic treatment of HAE,
About this update from Pharvaris N.v.
[{"type":"text","content":"Top-line data from CHAPTER-1, a proof-of-concept Phase 2 study of PHVS416 (immediate-release deucrictibant capsules) for the prophylactic treatment of HAE, anticipated by YE2023Executing from a strong financial position with cash and cash equivalents of €135 million as of March 31, 2023 ZUG, Switzerland, May 08, 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 reported financial results for the first quarter ended March 31, 2023 and provided a business update. “The Pharvaris team has made strong progress advancing our key studies and initiatives toward meaningful year-end milestones, including the anticipated reporting of topline CHAPTER-1 data and the submission of newly generated non-clinical toxicology data to the FDA to address the clinical holds in the U.S.,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The data presented at the C1-inhibitor Deficiency and Angioedema Workshop provide additional insights into the therapeutic profile of deucrictibant as potential treatment for HAE and other bradykinin-mediated diseases.” Recent Business Updates Top-line data from CHAPTER-1, a global Phase 2 study of PHVS416 (immediate-release deucrictibant capsules) for the prophylactic treatment of HAE attacks, anticipated by YE2023. CHAPTER-1 is currently on hold in the U.S. All CHAPTER-1 sites outside of the U.S. continue to recruit participants in the study. Based on the Company’s current assessment of the ex-U.S. regulatory status and enrollment rates, Pharvaris anticipates announcing top-line data by the end of 2023.Non-clinical toxicology study ongoing. A 26-week rodent toxicology study, which is intended to provide additional data to address the clinical holds in the U.S., is ongoing; the results from which Pharvaris anticipates submitting to the U.S. Food and Drug Administration (FDA) by the end of 2023.Clinical and non-clinical deucrictibant data presented at a recent medical meeting supports ongoing clinical development. Pharvaris presented data from clinical and non-clinical studies in two oral and three poster presentations at the 13th C1-inhibitor Deficiency and Angioedema Workshop, which was held from May 4-7, 2023, in Budapest, Hungary. Details of the presentations we...