Pharvaris’ deucrictibant meets primary endpoint in HAE attack trial

Pharvaris (PHVS) announced RAPIDe-3 pivotal data confirming the potential of deucrictibant’s differentiated profile for the on-demand treatment of hereditary angioedema – HAE attacks -. The data from Pharvaris’ first pivotal Phase 3 study will serve as the basis for marketing authorization applications, which are planned to be filed starting in the first half of 2026. The RAPIDe-3 global Phase 3, placebo-controlled study evaluated orally administered deucrictibant immediate-release capsule for the on-demand treatment of attacks in people 12 years and older with HAE. The primary endpoint and all 11 secondary efficacy endpoints, assessed sequentially under a multiplicity-control procedure, achieved statistical significance. Compared to placebo, deucrictibant demonstrated efficacy: faster median time to onset of treatment response, shorter median time to substantial symptom relief, earlier complete symptom resolution. Deucrictibant was well tolerated with no treatment-related serious adverse events and no participants discontinuing treatment due to treatment-emergent adverse events. An open-label extension of deucrictibant for the on-demand treatment of HAE attacks, RAPIDe-2 Part B, is ongoing. Pharvaris remains on track to submit a New Drug Application with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE.