Pharvaris is set to broaden the therapeutic scope of its investigational drug deucrictibant, announcing plans to launch a clinical trial for acquired angioedema this year. The expansion follows encouraging preliminary data demonstrating the drug's ability to halt or prevent swelling attacks in three patients.
The company is currently conducting multiple Phase 3 trials evaluating deucrictibant for hereditary angioedema (HAE), including CHAPTER-3 (NCT06669754) and NRAPIDe-3 (NCT06343779), with a third study, CHAPTER-4 (NCT06679881), scheduled to commence this year.
Dual Development Strategy
Pharvaris is pursuing two distinct formulations of deucrictibant to address different treatment needs. The immediate-release capsule (PHVS416) is being developed as an on-demand treatment for acute swelling attacks, while the extended-release tablet (PHVS719) is designed for daily prophylactic use.
The CHAPTER-3 trial, which began last year, is evaluating the extended-release formulation in approximately 81 participants aged 12 and older. Participants receive either a 40 mg daily dose of deucrictibant or placebo over 24 weeks, with results expected in the second half of 2026.
Simultaneously, the RAPIDe-3 trial is assessing the immediate-release capsule formulation, with top-line data anticipated in early 2026. This study will evaluate the drug's efficacy in reducing time to symptom relief during acute attacks.
Mechanism of Action and Disease Background
Deucrictibant functions as a small molecule antagonist of the bradykinin B2 receptor. By blocking this receptor, the drug aims to prevent bradykinin signaling, which is responsible for the vascular leakage that causes tissue swelling in both hereditary and acquired angioedema.
While HAE results from genetic mutations leading to bradykinin overproduction, acquired angioedema develops secondary to underlying conditions such as cancer or autoimmune diseases. These conditions reduce levels of C1-inhibitor protein, ultimately resulting in increased bradykinin and subsequent swelling attacks.
Expanding Clinical Program
"Pharvaris is committed to generating robust clinical data to build a compelling package supporting deucrictibant's efficacy and safety profile," stated Berndt Modig, Pharvaris' CEO. "Our team is focused on the execution of two Phase 3 clinical studies in HAE, the expansion of our pipeline into acquired angioedema, and preparations for commercialization of deucrictibant pending regulatory submission and approval."
The company's comprehensive development program includes CHAPTER-4, an open-label long-term extension study for the prophylactic treatment of HAE, and RAPIDe-2, a Phase 2/3 extension study evaluating the long-term safety and efficacy of the immediate-release formulation for on-demand treatment.
The expansion into acquired angioedema represents a significant milestone in deucrictibant's development program, potentially offering a new treatment option for patients with this challenging condition.
