Pivotal data on potential HAE treatment, deucrictibant, announced by pharmaceutical company
Topline data from a critical Phase-3 study investigating a potential new medicine for HAE, deucrictibant, has been announced by the pharmaceutical company, Pharvaris. The company reports that it remains on track to submit a New Drug Application (NDA) with the US FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE. The following is a summary of some key findings of the study:
- Primary endpoint met; median time to onset of symptom relief achieved in 28 hours, significantly faster versus placebo (p<0.0001)
- All secondary efficacy endpoints met (p<0.0001), including End of Progression (median 47 minutes) and complete symptom resolution (median 11.95 hours)
- Well-tolerated safety profile of deucrictibant confirmed
- Efficacy and safety outcomes consistent across all HAE subtypes represented (HAE type 1, HAE type 2, and HAE with normal C1 inhibitor) and varying attack severities and locations
Marc A Riedl, MD, MS, Professor of Medicine, Clinical Director of the US Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California San Diego (UCSD), and principal investigator in the RAPIDe-3 study, commented: “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.”
Berndt Modig, Chief Executive Officer of Pharvaris, added: “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. We are thrilled that RAPIDe-3 confirmed the profile of deucrictibant IR capsule established in Phase 2. If the CHAPTER-3 pivotal Phase 3 study confirms deucrictibant extended-release tablet as a long-term prophylactic of HAE attacks, deucrictibant could be the first and only oral therapy to offer control in both the on-demand and prophylactic treatment of bradykinin-mediated angioedema attacks.”
(Source: Pharvaris)