Business
Pharvaris Reports Second Quarter 2023 Financial Results and Provides Business Update
Enrollment completed in Phase 2 CHAPTER-1 prophylactic study; top-line data anticipated by YE2023Clinical hold lifted on deucrictibant for the on-demand
About this update from Pharvaris N.v.
[{"type":"text","content":"Enrollment completed in Phase 2 CHAPTER-1 prophylactic study; top-line data anticipated by YE2023Clinical hold lifted on deucrictibant for the on-demand treatment of HAE; initiation of global Phase 3 clinical study (RAPIDe-3) anticipated by YE2023Completed $70 million private placement; cash and cash equivalents of €179 million as of June 30, 2023 ZUG, Switzerland, Aug. 07, 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 second quarter ended June 30, 2023 and provided a business update. “The completion of enrollment in our Phase 2 CHAPTER-1 prophylactic HAE study, provides momentum as Pharvaris prepares to announce our first in-patient prophylactic clinical data by the end of the year,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Resolving the on-demand clinical hold of deucrictibant enables us to proceed with the clinical development of deucrictibant for the on-demand treatment of HAE; we intend to initiate our global Phase 3 on-demand study by the end the year. We are focused on resolving the remaining clinical hold on deucrictibant for the long-term prophylactic treatment of HAE in the U.S. We appreciate the ongoing support of our external partners, including the investors in our most recent financing, which we believe demonstrates excitement for the Pharvaris story, confidence in our team’s ability to execute against key initiatives, and the need for oral therapies for the treatment of HAE that are efficacious, safe, and easy to administer.” Recent Business Updates CHAPTER-1, a global Phase 2 study of deucrictibant for the prophylactic treatment of HAE attacks, has completed the enrollment. CHAPTER-1, which is currently on hold in the U.S., was designed to enroll approximately 30 patients globally with a goal of evaluating deucrictibant as an oral prophylaxis against HAE attacks, using PHVS416 (immediate-release deucrictibant capsules) as proof of concept. The efficacy and safety of deucrictibant (10 mg and 20 mg, twice-daily) and placebo will be evaluated by comparing the number of investigator-confirmed attacks during participants’ 12-week treatment period. Data from this proof-of-concept study is expected to inform the design ...