Clinical TrialSep 8, 2026, 06:56 AM
Pharvaris HAE Drug Deucrictibant XR Meets Phase 3 Trial Goals
AI Summary
Pharvaris N.V. announced positive topline data from its CHAPTER-3 pivotal Phase 3 study evaluating deucrictibant extended-release (XR) for the prevention of HAE attacks. The study met its primary endpoint, demonstrating an 83% reduction in attack rate compared to placebo, and all secondary efficacy endpoints were also met. Deucrictibant XR showed a well-tolerated safety profile. The company plans to submit marketing authorization applications in the first half of 2027. Additionally, topline data from the CREAATE study for AAE-C1INH attacks are expected in Q1 2027.
Key Highlights
- Pharvaris' CHAPTER-3 pivotal Phase 3 study of deucrictibant XR for HAE attacks met primary endpoint with 83% attack rate reduction vs placebo (p<0.0001).
- Study showed 87% attack rate reduction vs placebo in HAE Type 1 or Type 2 participants.
- All secondary efficacy endpoints were met with statistical significance.
- Deucrictibant XR demonstrated a well-tolerated safety profile with no treatment-related serious adverse events.
- Marketing authorization applications are planned to be submitted starting in the first half of 2027.
- Topline data from the CREAATE study for AAE-C1INH attacks are anticipated in Q1 2027.
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