Pharvaris has announced positive topline data from its RAPIDe-3 pivotal phase 3 study, confirming the potential of deucrictibant as an oral on-demand treatment for hereditary angioedema (HAE) attacks.
The trial met its primary endpoint, with a median time to onset of symptom relief achieved in 1.28 hours, significantly faster than placebo. All secondary efficacy endpoints were also met, including End of Progression at 17.47 minutes and complete symptom resolution at 11.95 hours.
The global study enrolled 134 participants across 24 countries, representing the most diverse patient population yet in an on-demand HAE trial. Results showed efficacy and safety outcomes consistent across all HAE subtypes and attack severities. Deucrictibant was well tolerated, with no treatment-related serious adverse events and no discontinuations due to side effects.
Marc A Riedl, Professor of Medicine at UC San Diego and principal investigator, 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.”
He added: “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.”
Peng Lu, Chief Medical Officer of Pharvaris, explained: “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.”
Berndt Modig, CEO of Pharvaris, added: “Deucrictibant combines the proven and effective mechanism of bradykinin B2 receptor antagonism in HAE with the convenience of oral administration. We are thrilled that RAPIDe-3 confirmed the profile of deucrictibant IR capsule established in phase 2.”
Pharvaris plans to submit a New Drug Application to the US Food and Drug Administration in the first half of 2026.
