Updates provided on deucrictibant, a potential HAE medicine currently being trialled in patients

A series of updates on deucrictibant, which is currently undergoing testing amongst HAE patients, were provided by the pharmaceutical company Pharvaris. The key updates shared with HAEi were:

  • RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment in March 2025; the study continues to assess HAE attacks in approximately 120 participants.
  • CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026.
  • Data from a recent food effect study, which further supports that the extended-release tablet can be administered with or without food, will be presented at an upcoming medical congress.
  • Following review of preclinical and clinical data, the U.S. Food and Drug Administration (FDA) has accepted Pharvaris’ TQT (through QT) study waiver requests. These waivers apply to the prophylactic program (IND153097) for deucrictibant extended-release formulation and the on-demand program (IND155872) for deucrictibant immediate-release formulation. Previously, Pharvaris has presented clinical and nonclinical data demonstrating that deucrictibant has no evident effect on cardiovascular parameters.

Berndt Modig, Chief Executive Officer of Pharvaris, said: “Our interactions with the HAE community combined with the regulatory receipt of orphan drug designation for deucrictibant in both the U.S. and EU, strengthen our belief that deucrictibant has the potential to address unmet needs of people living with all types of bradykinin-mediated angioedema, including those with HAE with normal C1 inhibitor and with AAE-C1INH. We will detail our plans to expand the potential treatment opportunities of deucrictibant beyond people with HAE type 1/2 during an R&D call in June. We are diligently working to achieve our clinical, regulatory, and pre-commercial aspirations for 2025 and bring deucrictibant to people living with bradykinin-mediated angioedema.”

(Source: Pharvaris)