Pharvaris (NASDAQ:PHVS), a late-stage biopharmaceutical company focused on oral treatments for bradykinin-mediated diseases, announced today the back-to-back publication of two Phase 2 clinical trials in The Lancet Haematology.
The studies, CHAPTER-1 and RAPIDe-1, provide peer-reviewed validation for deucrictibant as a potentially differentiated oral therapy for both the prevention (prophylaxis) and acute (on-demand) treatment of hereditary angioedema (HAE) attacks.
The CHAPTER-1 study, which evaluated an extended-release (XR) tablet for prophylaxis, demonstrated a statistically significant reduction in monthly HAE attack rates.
At the 40 mg/day dose, deucrictibant achieved an 84.5% reduction in attacks compared to placebo ($P=0.0008$).
Furthermore, final data from the open-label extension showed that the mean attack rate remained as low as 0.12 attacks per month for up to 34 months, with approximately half of the participants remaining entirely attack-free.
Patients also reported clinically meaningful improvements in health-related quality of life (HRQoL), specifically in the "functioning" and "fear and shame" domains.
The RAPIDe-1 study focused on the immediate-release (IR) capsule for on-demand treatment.
Results showed that deucrictibant significantly reduced attack severity and accelerated the time to symptom relief.
This proof-of-concept data was recently superseded by the pivotal Phase 3 RAPIDe-3 results, which met its primary endpoint with a median time to onset of symptom relief of just 1.28 hours—vastly outperforming the 12+ hours seen in the placebo group.
Deucrictibant was well tolerated across both studies, with a safety profile comparable to placebo and no treatment-related serious adverse events.
As Pharvaris moves into the second half of 2026, the company is preparing for a dual-track regulatory and clinical surge.
An NDA submission for the on-demand (acute) indication is expected in 1H 2026, backed by the RAPIDe-3 data.
Simultaneously, the company remains on track to release topline results from the pivotal Phase 3 CHAPTER-3 prophylaxis study in Q3 2026.