Swiss biopharma giant Pharvaris has announced that its pivotal Phase 3 RAPIDe-3 study confirmed the potential of deucrictibant, an oral bradykinin B2 receptor antagonist, as a fast-acting, on-demand treatment for hereditary angioedema (HAE). The results will form the foundation for marketing authorization applications planned for the first half of 2026.
The global, placebo-controlled RAPIDe-3 trial enrolled 134 participants across 24 countries and six continents, representing the most comprehensive and diverse HAE population studied to date, including adolescents and adults with HAE types 1, 2, and normal C1 inhibitor. The study met its primary endpoint and all 11 secondary efficacy endpoints, demonstrating statistically significant benefits across a broad spectrum of patients and attack severities.
Marc A. Riedl, principal investigator and Clinical Director at UCSD, said, “Bradykinin B2 receptor antagonism is a proven and effective mechanism for treatment of bradykinin-mediated angioedema. Injectable and oral on-demand therapies for HAE are available, however unmet medical needs remain.
"Effective, well-tolerated, and convenient acute treatment is an essential part of all HAE management plans due to unpredictable angioedema symptoms. The comprehensive and compelling outcomes of RAPIDe-3, specifically the fast treatment response and early complete symptom resolution, demonstrate the potential benefits of deucrictibant as an important on-demand treatment for people living with HAE.”
Pharvaris Chief Medical Officer Peng Lu, added, “I would like to sincerely thank the clinical study participants and their caregivers, the site investigators and staff, our study partners, the HAE community, and the Pharvaris team for their contributions to the RAPIDe-3 study. Together, we carefully designed and rigorously executed a study evaluating deucrictibant’s ability to effectively address the unmet needs and high expectations of physicians, regulators, payers, and, most importantly, people living with HAE.”
Dr Lu continued, “These clinically meaningful and statistically significant results demonstrate deucrictibant’s early-onset treatment response, fast symptom relief and resolution, and well-tolerated safety profile. This is an important step toward realizing deucrictibant’s potential to offer control of bradykinin-mediated angioedema attacks. With these data in hand, our team is working diligently to prepare for regulatory filings to enable access to this promising therapy.”
CEO Berndt Modig emphasized the innovation behind the drug: “Since its founding, Pharvaris has spent the last decade pioneering science for patient choice. Deucrictibant combines the proven and effective mechanism of bradykinin B2 receptor antagonism in HAE with the convenience of oral administration."
The therapy was well tolerated, with no treatment-related serious adverse events and no discontinuations due to adverse events, the company has said.
