Deucrictibant (PHVS416) - (CHAPTER-3)

September 8, 2026: Pharvaris (NASDAQ: PHVS) reported positive topline results from CHAPTER-3, a pivotal Phase 3 trial of deucrictibant XR 40 mg once daily for prevention of hereditary angioedema (HAE) attacks in adolescents and adults. In the 85-patient, double-blind, placebo-controlled study, deucrictibant XR met the primary endpoint, reducing mean monthly attack rate by 83% versus placebo across all HAE types (p<0.0001); in the 80 participants with HAE type 1 or 2, attack rate was reduced by 87% versus placebo. All secondary efficacy endpoints were also statistically significant.

The study included HAE type 1, type 2, and HAE with normal C1 inhibitor, which the company said makes CHAPTER-3 the first Phase 3 prophylaxis study across all three HAE types. Early protection was seen within the first week and was sustained through 24 weeks. Safety was described as well tolerated; most treatment-emergent adverse events were mild or moderate, with no treatment-related serious adverse events and one discontinuation for adverse events in each arm.

Pharvaris said CHAPTER-3 will support marketing applications starting in 1H 2027, including a planned U.S. NDA in 1H 2027. CHAPTER-4 is ongoing, and Phase 3 CREAATE topline data in AAE-C1INH are expected in Q1 2027.