Pharvaris Announces Phase 3 Clinical Study Design for Recently Initiated RAPIDe-3 Study, and Presents Quality-of-Life Improvement and Caregiver Behavior Data at Two Recent HAE Congresses

• The company announced the initiation of RAPIDe-3, the Phase 3 clinical trial evaluating the efficacy and safety of deucrictibant immediate-release capsule (PHVS416) for the treatment of HAE attacks
  

ZUG, Switzerland, March 18, 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, presented at two recent congresses: the 3^rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) and the 2024 HAE International (HAEi) Regional Conference Americas.

“We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris. “In collaboration with regulatory authorities we have designed a robust global study to assess the efficacy and safety of deucrictibant, a molecule which we believe has the potential to be best-in-class for both the prevention and treatment of HAE attacks.”

Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, added, “We hear from the HAE community that rapid onset and complete resolution of angioedema attacks with a single, easy-to-administer oral pill remains a high unmet need. The RAPIDe-3 study is designed to assess the effectiveness of deucrictibant in addressing that unmet need. To our knowledge, Pharvaris has been the first and only company to include and statistically power the novel endpoint ‘End of Progression’ in a pivotal study to show the first point at which medicine stops the worsening of the symptoms of an HAE attack, recognized by people living with HAE and physicians, and which could differentiate deucrictibant from other HAE therapies. We are also presenting quality-of-life data from our prophylaxis study, CHAPTER-1, and a real-world, cross-sectional survey, both of which continue to inform us of the unmet needs in the HAE community and how deucrictibant could potentially address those needs.”

The design of the Phase 3 RAPIDe-3 study was showcased for the first time in two posters on Friday. One titled “Design of RAPIDe-3 Phase 3 Trial: Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks” was presented by Mauro Cancian, M.D., Ph.D., at the ITACA meeting and the second, titled “Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks: RAPIDe-3 Phase 3 Trial Design” was presented by Anete Grumach, M.D., Ph.D., at the HAEi Americas Congress. RAPIDe-3 is a randomized, double-blind, placebo-controlled, crossover study, which is designed to enroll approximately 120 adolescent and adult participants globally. 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, and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S).