Pharvaris' Deucrictibant Shows Rapid Efficacy in HAE Attacks, Awaits…

Event summary

Phase 3 RAPIDe-3 study results published in The Lancet show deucrictibant IR achieves symptom relief in 1.28 hours and complete resolution in 11.95 hours for HAE attacks.
Deucrictibant IR met all primary and secondary endpoints with high statistical significance and demonstrated a well-tolerated safety profile.
NDA and MAA for deucrictibant IR under review by FDA and EMA with PDUFA target action date of April 23, 2027.
Pharvaris aims to be the first to offer an approved oral bradykinin B2 receptor antagonist for HAE treatment.

The big picture

Pharvaris' deucrictibant IR represents a potential paradigm shift in HAE treatment, offering oral administration with efficacy comparable to injectables. The successful Phase 3 results position the drug as a strong candidate for regulatory approval, which could expand treatment options for patients with bradykinin-mediated angioedema. The broader clinical development strategy, including prophylactic applications, underscores Pharvaris' ambition to dominate this niche therapeutic area.

What we're watching

Regulatory Approval: Whether the FDA and EMA will approve deucrictibant IR by the April 2027 target date, potentially making it the first oral bradykinin B2 receptor antagonist for HAE.
Market Differentiation: How Pharvaris positions deucrictibant IR against existing injectable treatments and emerging therapies in the HAE market.
Clinical Expansion: The pace at which Pharvaris advances deucrictibant into prophylactic settings and other bradykinin-mediated conditions like AAE-C1INH.