Pharvaris (PHVS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Key clinical results and product development

• Achieved two phase III successes for deucrictibant in hereditary angioedema (HAE) within a year, with strong efficacy in both on-demand and prophylactic settings.

• Deucrictibant is the only orally available B2 receptor antagonist, suitable for both on-demand and prophylaxis, aiming to address all HAE types and acquired angioedema.

• Phase III data showed 87% attack rate reduction in type 1 and 2 HAE, outperforming phase II, attributed to the extended-release formulation and broader patient inclusion.

• Type 3 HAE patients included in the study showed significant improvement, with one patient achieving 90% reduction in laryngeal attacks and another attack-free for six months.

• Plans to include acquired angioedema data in regulatory filings, with top-line results from the CREAATE study expected in Q1 next year.

Safety and tolerability insights

• Only one serious adverse event (laryngeal dyskinesia) reported, not related to laryngeal swelling, with the patient experiencing substantial benefit from treatment.

• No bilirubin elevation observed in patients with grade 3 liver enzyme elevations; both had no symptoms and confounding factors such as fatty liver and androgen use.

• Hepatic enzyme elevations are common in HAE trials due to patient history and comorbidities; safety profile is comparable to other prophylactic treatments.

Commercial strategy and market outlook

• On-demand launch targeted for April next year, with prophylaxis launch to follow regulatory review.

• Pricing strategy will consider both on-demand and prophylactic indications, aiming for flexibility and maximizing portfolio value.

• U.S. launch infrastructure is being built to support both indications from day one, leveraging experienced leadership and a unified sales force.

• Ex-U.S. strategy focuses on market access and tailored organizational size, with prophylaxis seen as the larger opportunity.