Pharvaris Announces Positive Results for Deucrictibant XR in HAE Prophylaxis Study

Pharvaris, a late-stage biopharmaceutical company focused on developing novel oral bradykinin B2 receptor antagonists, announced positive results from its pivotal Phase 3 study evaluating deucrictibant extended-release (XR) tablet for the prevention of hereditary angioedema (HAE) attacks. The study, called CHAPTER-3, demonstrated an 83% reduction in the attack rate among all types of HAE, including HAE Type 1 and Type 2, compared to a placebo.

The global, double-blind, placebo-controlled study randomized 85 participants from 21 countries in a 2:1 ratio to receive deucrictibant XR (40 mg, once daily) or placebo for 24 weeks. Primary and secondary efficacy endpoints were all met with statistical significance, with a 87% reduction in attack rate observed in people with HAE Type 1 or Type 2. The primary endpoint, which measured the mean monthly attack rate, was consistent across subgroups. Additionally, deucrictibant XR was well tolerated, with most treatment-emergent adverse events being mild or moderate. There were no serious adverse events related to the treatment.

The study showed early-onset protection within the first week, which was sustained throughout the 24-week treatment period. Participants treated with deucrictibant XR experienced significant improvements in attack-free periods, further supporting the efficacy of the drug. According to Marc A. Riedl, M.D., principal investigator of the study, the results confirm the value of targeting the bradykinin B2 receptor for both the prevention and treatment of HAE attacks.

Peng Lu, M.D., Ph.D., President of Pharvaris, expressed excitement about the potential of deucrictibant XR, stating, "People living with HAE have been waiting for a well-tolerated oral therapy with injectable-like efficacy. Deucrictibant XR could be the first and only oral therapy to offer this combination, addressing an unmet need in the HAE community."

The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027. Pharvaris also intends to present additional efficacy, safety, and participant experience data from the CHAPTER-3 study at upcoming medical congresses.

Pharvaris is currently evaluating deucrictibant XR for both prophylaxis and on-demand treatment of HAE. The company is also conducting an open-label long-term extension study of deucrictibant XR for the prophylaxis of HAE attacks. Topline data from Part 1 of CREAATE, a global, pivotal Phase 3 study evaluating deucrictibant XR for the prevention of angioedema attacks due to C1 inhibitor deficiency (AAE-C1INH), are anticipated in the first quarter of 2027.