Pharvaris (Nasdaq: PHVS) announced that its CHAPTER-3 Phase 3 clinical trial of deucrictibant extended-release (XR) tablet met its primary endpoint, reducing hereditary angioedema (HAE) attack rates by 83% versus placebo (p<0.0001) in participants with all three types of HAE.

The double-blind, placebo-controlled study enrolled 85 participants from 21 countries, randomized in a 2:1 ratio to receive deucrictibant XR at 40 mg once daily (N=55) or placebo (N=30) over 24 weeks. In the 80 participants with HAE Type 1 or Type 2, the mean monthly attack rate was 87% lower in the deucrictibant XR group compared to placebo. All secondary efficacy endpoints were met with statistical significance. The company said protection was observed within the first week and sustained through the 24-week treatment period.

Deucrictibant XR was reported as well tolerated, with most treatment-emergent adverse events characterized as mild or moderate. No treatment-related serious adverse events were reported, and one participant in each group discontinued treatment due to an adverse event.

Marc A. Riedl, principal investigator in the study, said the results "further confirm the value of targeting the bradykinin B2 receptor for both the prevention and treatment of attacks across all types of HAE."

Pharvaris said data from the CHAPTER-3 study will serve as the basis for marketing authorization applications, planned for submission starting in the first half of 2027. The company also plans to submit a New Drug Application to the U.S. Food and Drug Administration for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027.

A separate open-label long-term extension study, CHAPTER-4, is ongoing. Topline data from the CREAATE Phase 3 study evaluating deucrictibant XR for acquired angioedema due to C1 inhibitor deficiency are anticipated in the first quarter of 2027.

Pharvaris said it plans to present additional data from CHAPTER-3 at upcoming medical congresses.