Pharvaris (PHVS) Study Update summary

Study background and design

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

• The study population was highly representative, with a median age of 38 years, 97% having HAE Type 1 or 2, and included patients with normal C1 inhibitor.

• Each participant treated two qualifying attacks, with 88 paired attacks included in the primary efficacy analysis.

• Patient-reported outcomes (PGIC and PGIS) were used as primary efficacy measures.

• The study is the first pivotal trial to enroll HAE patients with normal C1 inhibitor.

Key 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 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 by PGI-S and PGI-C, significantly faster than placebo (p<0.0001).

• Complete symptom resolution was achieved in 11.95 hours with deucrictibant versus not estimable for placebo within 48 hours (p<0.0001).

• 83% of attacks were resolved with a single capsule within 12 hours, and 93% 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 TEAEs leading to discontinuation were reported.

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

• No treatment-related serious adverse events or discontinuations due to adverse events were reported.