Pharvaris Reports 1.28-Hour Symptom Relief and 92% Attack Reduction
PHVS•Phase 3 RAPIDe-3 trial: median symptom relief 1.28 hours versus over 12 hours for placebo; 83.0% of attacks resolved with one 20 mg capsule and 93.2% required no rescue medication. Phase 2 CHAPTER-1 extension showed a 92% reduction in HAE attack rates and 50% of participants were attack-free over 34 months.
1. Phase 3 RAPIDe-3 On-Demand Efficacy and Safety
The RAPIDe-3 global Phase 3, placebo-controlled study evaluated a 20 mg oral deucrictibant capsule for on-demand treatment of HAE attacks in participants aged 12 and older. Results showed rapid and sustained efficacy, with median onset of symptom relief in 1.28 hours versus over 12 hours for placebo and median complete resolution in 11.95 hours versus over 48 hours. A single capsule sufficed in 83.0% of attacks, 93.2% of attacks required no rescue medication, and there were no treatment-related serious adverse events or discontinuations due to adverse events.
2. End of Progression™ Endpoint Achievements
RAPIDe-3 uniquely assessed End of Progression™ (EoP) as a prespecified efficacy endpoint, defining it as the point when symptoms cease worsening. Deucrictibant achieved a median time to EoP of 17.47 minutes versus 228.67 minutes for placebo, with 92.8% of treated attacks reaching EoP within 12 hours and 97.4% doing so with a single capsule.
3. Long-Term Prophylaxis Results and Safety Margins
In the Phase 2 CHAPTER-1 open-label extension, participants treated with oral deucrictibant for up to 34 months experienced a sustained ~92% reduction in HAE attack rates and roughly half remained attack-free throughout the period, with no treatment-related serious adverse events. Analysis of combined use of a 40 mg extended-release tablet for prophylaxis and up to two 20 mg immediate-release capsules for breakthrough attacks demonstrated adequate safety margins based on clinical and nonclinical data.
