Pharvaris (PHVS) investor relations material

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.