Pharvaris Phase 3 Trial Cuts Monthly HAE Attack Rate 83%; FDA Filing Planned for 2027

Key Facts

Pharvaris said on September 8, 2026 that deucrictibant XR tablets reduced the mean monthly hereditary angioedema (HAE) attack rate by 83% versus placebo in the pivotal CHAPTER-3 Phase 3 trial, meeting the primary endpoint at p<0.0001 in company-reported topline results.

CHAPTER-3 was a global, double-blind, placebo-controlled study of a 40 mg oral dose given once daily. It enrolled 85 participants across 21 countries and randomized them 2:1 to deucrictibant XR or placebo—55 and 30 participants, respectively—for 24 weeks.

In an analysis of 80 participants with HAE Type 1 or Type 2, the mean monthly attack rate was 87% lower with deucrictibant XR than with placebo. The company said the primary-endpoint result was consistent across subgroups.

The trial also met all secondary efficacy endpoints with statistical significance. Pharvaris said protection emerged during the opening week and was sustained throughout the 24-week treatment period, alongside fewer attacks and a higher proportion of attack-free participants.

The company said deucrictibant XR was well tolerated and that most treatment-emergent adverse events were mild or moderate. No treatment-related serious adverse events were reported, while 1 participant in each group discontinued treatment because of an adverse event.

Deucrictibant is an oral small molecule that blocks the bradykinin B2 receptor, a pathway involved in angioedema attacks. Pharvaris is developing the extended-release XR formulation for sustained preventive coverage alongside a separate immediate-release formulation for on-demand treatment.

The results advance the XR program toward its next regulatory step but do not constitute marketing approval. Pharvaris plans to begin marketing-authorization submissions in the first half of 2027, including a New Drug Application to the FDA for prevention of bradykinin-mediated angioedema attacks.

Pharvaris plans to present additional efficacy, safety and participant-experience data at upcoming medical congresses. The open-label, long-term CHAPTER-4 study of deucrictibant XR for HAE prophylaxis is also continuing.