Alignment with regulatory agencies following End-of-Phase 2 meetings for the prophylactic development of deucrictibant; global startup activities of CHAPTER-3, pivotal Phase 3 study of deucrictibant for the prevention of hereditary angioedema (HAE) attacks, underway Enrollment of RAPIDe-3, a global pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, progressing as planned Executing from a strong financial position with cash and cash equivalents of €344 million as of June 30, 2024 ZUG, Switzerland, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Pharvaris (NASDAQ:PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the financial results for the second quarter ended June 30, 2024, and provided a business update. "Pharvaris supports the view of the HAE community that achievement of complete control of the disease and normalization of lives of people with HAE through long-term prophylaxis are the main goals of treatment in HAE. Obtaining alignment with regulatory agencies on our proposed global clinical development plan for deucrictibant as a prophylactic HAE treatment is an important milestone for the company," said Berndt Modig, Chief Executive Officer of Pharvaris. "RAPIDe-3 enrollment is progressing as planned, and CHAPTER-3 start-up activities are underway globally. Diligent execution of the RAPIDe-3 and the CHAPTER-3 pivotal clinical studies remains our top priority, with the goal of establishing differentiated data packages for deucrictibant in both on-demand and prophylaxis. Data from the ongoing open-label extensions in both on-demand and prophylaxis, as well as supplemental analyses from the RAPIDe-1 and CHAPTER-1 studies, will be presented at upcoming medical meetings. Pharvaris continues to operate from a strong financial position with a disciplined approach as we aspire to bring best-in-class oral therapies to the HAE community." Recent Business UpdatesDevelopment Pipeline Alignment with regulatory authorities achieved regarding design of CHAPTER-3, a global Phase 3 study of deucrictibant for the prophylactic treatment of HAE. Pharvaris sought feedback and obtained alignment on key elements of a Phase 3 clinical study design during End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA), the European Union Committee for Medicinal Products for Human Use (CHMP), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). CHAPTER-3 is planned as a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablets for the prophylactic treatment of HAE attacks. The study aims to enroll approximately 81 adult and adolescent participants (12 years and older) with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablets (40 mg/day) or placebo once daily for 24 weeks. The primary endpoint of the study is to evaluate the efficacy of deucrictibant compared to placebo for prophylaxis against angioedema attacks as measured by the time-normalized number of investigator-confirmed HAE attacks during the 24-week treatment period. Other objectives of the study include evaluating additional clinically relevant outcomes, deucrictibant's safety and tolerability, pharmacokinetics, and its impact on health-related quality of life in the prophylactic setting. Advancing RAPIDe-3 (NCT06343779), a global Phase 3 clinical study. RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsules for the on-demand treatment of HAE attacks is progressing as planned with a target enrollment of approximately 120 participants. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least "a little better" for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of ...