On Tuesday, Pharvaris NV (NASDAQ:PHVS) reported positive topline results from its late-stage clinical trial evaluating the oral drug deucrictibant extended-release (XR) for preventing hereditary angioedema (HAE) attacks.
Following the announcement, the stock jumped over 17%.
The trial met all primary and secondary efficacy endpoints, paving the way for regulatory applications planned for the first half of 2027.
Rapid Onset And Sustained Protection
The global, double-blind CHAPTER-3 trial evaluated a 40 mg daily dose of deucrictibant XR against a placebo over 24 weeks.
The study enrolled 85 participants. Notably, it stands as the only Phase 3 prophylaxis study to include patients with HAE type 1, HAE type 2, and HAE with normal C1 inhibitor.
Patients receiving the daily tablet experienced an 83% reduction in their mean monthly attack rate compared to the placebo group.
For the 80 participants specifically diagnosed with HAE Type 1 or Type 2, the therapy reduced the monthly attack rate by 87%.
The clinical data indicated that participants achieved protection within the first week of treatment. The defensive benefit persisted throughout the entire 24-week study duration, leading to robust increases in the number of attack-free patients.
Favorable Safety Profile And Next Steps
Participants tolerated the treatment well. Researchers observed mostly mild to moderate adverse events and reported no treatment-related serious adverse events.
Only one patient in each study arm discontinued the trial due to an adverse event.
Following these successful results, the company plans to submit a New Drug Application to the U.S. Food and Drug Administration in early 2027. Meanwhile, the CHAPTER-4 open-label extension study continues monitoring long-term effects.
Additionally, the company expects topline data from a separate Phase 3 trial for acquired angioedema in the first quarter of 2027.
PHVS Stock Price Activity: Pharvaris shares were up 17.02% to $41.25 at the time of publication on Tuesday, according to Benzinga Pro data.
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