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Pharvaris (PHVS) investor relations material

Pharvaris Study Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study Update summary3 Dec, 2025

Study background and design

  • RAPIDe-3 was a global, double-blind, placebo-controlled, crossover Phase 3 study evaluating deucrictibant immediate release capsule (20 mg) for on-demand treatment of hereditary angioedema (HAE) attacks, enrolling 134 participants (124 adults, 10 adolescents) from 24 countries and including all HAE subtypes and both on-demand and prophylactic patients.

  • The study population was diverse, with a median age of 38 years, 70% Caucasians, 14% Asians, 7% Black or African Americans, and 97% having HAE Type 1 or 2.

  • Each participant treated two qualifying attacks, with efficacy analyses based on 88 paired attacks.

  • Approximately 23% of patients were on long-term prophylactic treatment, mainly lanadelumab.

  • The study included patients on or off long-term prophylaxis and all HAE subtypes, including those with normal C1 inhibitor.

Efficacy results

  • Deucrictibant met the primary endpoint, achieving a median onset of symptom relief at 1.28 hours versus over 12 hours for placebo (p<0.0001).

  • End-of-progression was achieved in a median of 17.47 minutes for deucrictibant versus 228.67 minutes for placebo (p<0.0001).

  • Substantial symptom relief was reached in a median of 2.41–2.85 hours, and complete symptom resolution occurred in 11.95 hours with deucrictibant, both significantly faster than placebo.

  • By 4 hours, 85% of deucrictibant-treated attacks achieved symptom relief, compared to 30% for placebo.

  • 83% of attacks were treated with a single capsule, and 93.2% did not require rescue medication.

Safety and tolerability

  • Deucrictibant was well tolerated, with most adverse events being mild or moderate and no discontinuations due to treatment-emergent adverse events.

  • Two serious adverse events occurred in each group, but none led to discontinuation; no fatal events or treatment-related serious adverse events were reported.

  • TEAEs were reported in 24% of deucrictibant-treated participants, with one severe and one life-threatening event.

  • No safety signals were identified from adverse events, labs, ECG, or vital signs.

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Frequently asked questions

Pharvaris N.V. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for rare diseases, particularly hereditary angioedema (HAE). The company specializes in creating oral bradykinin B2 receptor antagonists, offering alternatives to existing injected treatments. Its key developments include PHVS416, a soft capsule for on-demand use during acute HAE attacks, and PHVS719, an extended-release tablet aimed at preventing such attacks. Pharvaris operates primarily in the Netherlands, Switzerland, and the United States. The company is headquartered in Leiden, the Netherlands, and its shares are listed on the NASDAQ.

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