Business
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
About this update from Pharvaris N.v.
[{"type":"text","content":"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 3rd 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 Attac...