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Sep 8, 2026Clinical readout

Pharvaris reports positive Phase 3 CHAPTER-3 results for deucrictibant XR in HAE prophylaxis

The company said the trial met its primary and secondary endpoints, with plans to file for marketing authorization starting in the first half of 2027.

Pharvaris announced on September 8, 2026 that its Phase 3 CHAPTER-3 study of deucrictibant extended-release (XR) tablet met its primary endpoint for preventing hereditary angioedema (HAE) attacks. Treatment with deucrictibant XR in participants with all types of HAE reduced the mean monthly attack rate by 83% compared with placebo, a result the company said was statistically significant with p<0.0001.1

Looking specifically at the 80 participants with HAE Type 1 or Type 2, the drug showed an 87% reduction in mean monthly attack rate versus placebo.1 The company said these primary endpoint results held up across different subgroups of patients.1

Pharvaris said all secondary efficacy endpoints, which were evaluated in sequence using a procedure to control for multiple comparisons, also reached statistical significance.1

The trial design called for daily oral dosing. The global, double-blind, placebo-controlled study tested a 40 mg once-daily deucrictibant XR tablet for preventing attacks in adolescents and adults with HAE.1 Enrollment totaled 85 participants across 21 countries, split roughly two to one between the drug arm (55 patients) and placebo (30 patients) over a 24-week treatment period.1

On safety, the company reported that deucrictibant XR was generally well tolerated, with most side effects rated mild or moderate, no treatment-related serious adverse events, and one patient in each arm stopping treatment due to an adverse event.1

Looking ahead, Pharvaris said the CHAPTER-3 data will support marketing authorization applications it plans to begin submitting in the first half of 2027.1 A related open-label extension study, CHAPTER-4, is still ongoing.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.