Announcement • Sep 08

Pharvaris Announces Positive Topline Data From CHAPTER-3 Pivotal Study Of Deucrictibant XR For Prophylaxis Of HAE Attacks

Pharvaris announced statistically significant and clinically meaningful topline results of the CHAPTER-3 pivotal Phase 3 study evaluating deucrictibant extended-release (XR) tablet for the prevention of HAE attacks. The primary endpoint and all secondary efficacy endpoints were met with statistical significance. Data from the CHAPTER-3 study will serve as the basis for marketing authorization applications, which are planned to be submitted starting in the first half of 2027. The CHAPTER-3 (NCT06669754) global Phase 3, double-blind, placebo-controlled study evaluated orally administered deucrictibant XR tablet (40 mg, once daily) for the prevention of attacks in adolescents and adults with HAE. CHAPTER-3 is the first and only prophylaxis Phase 3 study to evaluate all three types of HAE, including people with HAE type 1, HAE type 2, or HAE with normal C1 inhibitor. The study randomized 85 participants from 21 countries in a 2:1 ratio to deucrictibant XR (N=55) or placebo (N=30) for 24 weeks of treatment. Treatment with deucrictibant XR in participants with all types of HAE reduced the mean monthly attack rate by 83%. 87% attack rate reduction versus placebo was observed in people with HAE Type 1 or Type 2. All secondary efficacy endpoints were met with statistical significance. Deucrictibant XR demonstrated a well-tolerated safety profile. Pharvaris plans to present additional efficacy, safety, and participant experience data from the CHAPTER-3 study at upcoming medical congresses. The CHAPTER-4 open-label long-term extension study of deucrictibant XR for the prophylaxis of HAE attacks is ongoing. Topline data from Part 1 of CREAATE (NCT07266805), a global, pivotal Phase 3 study evaluating orally-administered deucrictibant XR for the prevention of AAE-C1INH attacks, are anticipated in the first quarter of 2027. Enrollment in CREAATE is ongoing and progressing as planned. Pharvaris 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. Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic.

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Pharvaris Announces Positive Topline Data From CHAPTER-3 Pivotal Study Of Deucrictibant XR For Prophylaxis Of HAE Attacks

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