Clinical Read2026-09-30

Deucrictibant (PHVS416) - (CHAPTER-3)

Pharvaris N.V.PHVS
Indication
Hereditary angioedema - prophylactic use
Stage
phase3
Event
Topline Data
Details

April 2, 2026: Pharvaris (NASDAQ: PHVS) reported Q4/full-year 2025 results and provided late-stage pipeline updates for deucrictibant (oral bradykinin B2 receptor antagonist) in hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE‑C1INH).

  • Deucrictibant XR prophylaxis (HAE): Enrollment completed in CHAPTER-3 (NCT06669754), a randomized, double-blind, placebo-controlled Phase 3 study (~81 participants; 2:1 deucrictibant XR 40 mg vs placebo; once daily for 24 weeks). Topline data are anticipated in 3Q2026. CHAPTER-4 (NCT06679881), an open-label long-term extension evaluating safety/effectiveness of XR 40 mg/day for HAE prophylaxis, is enrolling as planned.

  • Deucrictibant IR on-demand (HAE): U.S. NDA submission remains on track for 1H2026, based on RAPIDe-3 and RAPIDe-2. RAPIDe-3 (NCT06343779) data presented at the AAAAI 2026 Annual Meeting met the primary and all 11 secondary endpoints; median onset of symptom relief was 1.28 hours and complete symptom resolution 11.95 hours vs placebo.

  • AAE‑C1INH (prophylaxis and on-demand): Enrollment in the pivotal Phase 3 CREAATE study (NCT07266805) is progressing as planned (XR prophylaxis, IR crossover on-demand, plus open-label extension).

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