RAPIDe-3, a global pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, is currently enrolling End-of-Phase 2 meeting scheduled to discuss development plan of deucrictibant for the prophylaxis of HAE attacks Strengthened executive committee with hiring of David Nassif, J.D., Chief Financial Officer, and Stefan Abele, Ph.D., as Chief Technical Operations Officer UK Innovation Passport awarded to deucrictibant for both the on-demand and prophylactic treatment of HAE attacks Ended 2023 with cash and cash equivalents of approximately €391 million ZUG, Switzerland, April 10, 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 reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update. "2024 is off to a strong start, supported by the incredible momentum we built in an impressive 2023—driven by a second positive data readout of deucrictibant that was validated by the support of our investors," said Berndt Modig, Chief Executive Officer of Pharvaris. "At the start of the year, the lift of the remaining hold on the prophylaxis program in the U.S. allowed us to progress with the global Phase 3 clinical development plans for deucrictibant for prevention of HAE attacks. As we move toward the initiation of CHAPTER-3, we hope to realize the promise of the proof-of-concept CHAPTER-1 data, which support deucrictibant's potential to be a best-in-class oral prophylactic therapy. We are pleased with the HAE community's excitement in RAPIDe-3, which is enrolling as planned; we will provide the anticipated timing of topline data as enrollment progresses and data is accumulated. Receipt of the Innovation Passport designation for deucrictibant in the UK reflects regulatory recognition of deucrictibant's innovation for better treatment options for people living with HAE." Recent Business Updates and HighlightsDevelopment Pipeline Enrollment initiated in RAPIDe-3 (NCT06343779) a global Phase 3 clinical study. Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) of at least "a little better" for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of Progression (EoP) in attack symptoms within 12 hours as measured by PGI-C, substantial symptom relief, and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S) and by Angioedema Symptom Rating Scale (AMRA). End-of-Phase 2 meeting scheduled to align on prophylactic Phase 3 clinical development plan. Pharvaris continues preparatory activities for CHAPTER-3, a global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks. An End-of-Phase 2 meeting has been scheduled with the U.S. Food and Drug Administration (FDA), during which Pharvaris will seek feedback and alignment on the key elements of the proposed clinical development plan. Deucrictibant awarded UK Innovation Passport. The UK Innovative Licensing and Access Pathway (ILAP) Steering Group, which consists of the All Wales Therapeutics and Toxicology Centre (AWTTC), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC), has awarded an Innovation Passport to deucrictibant for the on-demand and prophylactic treatment of HAE attacks in people 12 years and older. The Innovation Passport is the entry point for the ILAP, which has a goal of accelerating the time to access to medicines in the UK, and receipt of the award activates the MHRA, NICE, SMC, and other agencies to develop a roadmap for regulatory ...