Pharvaris Announces Positive Topline Data from RAPIDe-3 Pivotal Study Confirming Potential of Deucrictibant for On-Demand Treatment of HAE Attacks

Core Insights - Pharvaris announced pivotal data from the RAPIDe-3 study, confirming the efficacy of deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks, with plans for marketing authorization applications in the first half of 2026 [1][7] Study Design and Results - The RAPIDe-3 study was a global Phase 3, placebo-controlled trial involving 134 participants from 24 countries, assessing the immediate-release (IR) capsule of deucrictibant (20 mg) for HAE treatment [2] - The study achieved statistical significance for the primary endpoint and all 11 secondary efficacy endpoints, making it the first on-demand HAE study compliant with the Core Outcome Set recommended in the AURORA consensus [2][3] Efficacy and Safety - Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo (p<0.0001) [3][4] - All secondary efficacy endpoints were met, including a median time to End of Progression™ of 17.47 minutes and complete symptom resolution in 11.95 hours [3][4] - The safety profile of deucrictibant was well-tolerated, with no serious adverse events reported [5][9] Future Plans - Pharvaris is preparing to submit a New Drug Application (NDA) to the FDA in the first half of 2026 for deucrictibant as an on-demand treatment for HAE attacks [7][10] - An ongoing open-label extension study (RAPIDe-2 Part B) will provide additional efficacy and safety data [7] Company Overview - Pharvaris is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated conditions, including HAE [10] - The company aims to provide therapies that combine injectable-like efficacy with the convenience of oral administration [10]