Oral Deucrictibant Shows Fast Relief in Phase 3 Hereditary Angioedema Trial
Pharvaris reported that its Phase 3 RAPIDe-3 trial of oral deucrictibant immediate-release 20 mg in adolescents and adults with hereditary angioedema attacks was published in The Lancet. The study found faster onset of symptom relief at 1.28 hours and complete symptom resolution at 11.95 hours compared with placebo, while the drug was well tolerated. The company said its NDA and MAA for on-demand treatment of HAE attacks are under regulatory review.
Pharvaris said the Phase 3 RAPIDe-3 trial, a global randomized, double-blind, placebo-controlled crossover study, evaluated a 20 mg immediate-release oral capsule of deucrictibant in adolescents and adults experiencing HAE attacks. The trial met its primary endpoint and all 11 secondary endpoints, with results published in The Lancet.
Findings were consistent across subgroups by age, region, HAE type — including HAE with normal C1 inhibitor — long-term prophylaxis use, and attack severity and location, including non-severe laryngeal attacks. Most attacks were controlled with one capsule. An open-label extension, RAPIDe-2, continues, and a U.S. expanded access program is available.
If approved, deucrictibant IR could become the first oral bradykinin B2 receptor antagonist for on-demand HAE treatment, potentially offering patients a more convenient alternative to current approaches. Faster relief and resolution may ease the burden attacks place on patients, caregivers, and health systems. Regulatory decisions in the U.S. and Europe could shape how quickly access arrives, while cost and coverage may influence real-world reach.