Pharvaris deucrictibant Phase 3 HAE data presented at EAACI 2026
Pharvaris has presented a suite of clinical data for its oral bradykinin B2 receptor antagonist deucrictibant at the European Academy of Allergy and Clinical Immunology Annual Congress in Istanbul, covering on-demand efficacy, long-term prophylaxis, combination dosing and cardiovascular safety.
The headline dataset came from the global Phase 3 RAPIDe-3 study (NCT06343779), which enrolled patients aged 12 and over with hereditary angioedema (HAE), including those with normal C1 inhibitor levels. In the on-demand setting, deucrictibant achieved a median time to symptom relief of 1.28 hours compared with more than 12 hours on placebo, and a median time to complete resolution of 11.95 hours versus more than 48 hours. The company said 83% of treated attacks were managed with a single 20 mg capsule, and 93.2% did not require rescue medication.
End of Progression endpoint
A separate oral presentation focused on the End of Progression (EoP) measure, which Pharvaris describes as the earliest timepoint at which symptoms stop worsening. RAPIDe-3 is the first HAE study to include EoP as a prespecified endpoint. Deucrictibant reached the EoP threshold at a median of 17.47 minutes, against 228.67 minutes for placebo. In 97.4% of deucrictibant-treated attacks that met EoP, a single capsule sufficed.
Anne Lesage, Chief Early Development Officer at Pharvaris, addressed the cardiovascular dataset in a separate presentation, noting the particular scrutiny applied to agents that modulate the kallikrein-kinin system. An integrated analysis across approximately 570 patients found no evidence of QT prolongation, serious arrhythmia, or clinically meaningful haemodynamic changes. "Deucrictibant has a cardiovascular profile showing no evidence of increased risks or of QT prolongation nor clinically meaningful cardiac risks," Lesage said, adding that these findings spanned multiple doses and nearly three years of long-term treatment.
Long-term prophylaxis data from the completed CHAPTER-1 open-label extension (NCT05047185) showed attack frequency reduced by approximately 92% from baseline, with roughly half of participants remaining attack-free throughout the extension. All participants reported well-controlled disease from week 62 to study end, and quality-of-life improvements were observed as early as week four and maintained through week 134.
Market context and regulatory path
HAE is a rare inherited condition estimated to affect approximately one in 50,000 people. The current standard of care is dominated by injectable therapies, including plasma-derived C1 inhibitor concentrates and the subcutaneous kallikrein inhibitor lanadelumab. The oral segment remains less crowded; Kalvista Pharmaceuticals, now acquired by Takeda, has advanced sebetralstat in on-demand oral treatment, while Astria Therapeutics is pursuing garadacimab, an injectable factor XIIa inhibitor, as a prophylactic. Pharvaris is differentiating on the combination of a rapid-onset oral capsule and an extended-release tablet for prophylaxis, covering both treatment settings with the same molecule.
Pharvaris has said it is preparing marketing authorisation applications for the immediate-release capsule as an on-demand treatment and expects topline data from the pivotal Phase 3 CHAPTER-3 prophylaxis study in the third quarter of 2026. A Phase 3 study in acquired angioedema due to C1 inhibitor deficiency (CREAATE) is also ongoing, broadening the addressable patient population beyond classic HAE. Deucrictibant holds orphan drug designation from the FDA, European Commission, and Swissmedic, which confers regulatory and commercial incentives that will be relevant as the company approaches potential first approvals.