Pharvaris (PHVS) Leerink Global Healthcare Conference 2025 summary

Clinical development progress

• Two phase III studies are ongoing: one for prophylactic use and one for on-demand treatment, with the on-demand trial initiated a year ago and the prophylactic trial started at the beginning of this year.

• Guidance for phase III on-demand pivotal data is set for Q1 2026, with enrollment progressing well and a crossover design allowing some patients to remain on prophylactic therapy.

• The phase III prophylactic trial uses an extended-release tablet and aims for a straightforward reduction in attack rate, with a 2:1 randomization and a 40 mg dose.

• Phase II data showed an 87% reduction in attacks, with even higher efficacy in moderate to severe cases, setting high expectations for phase III.

• A small, pivotal study in acquired angioedema is planned, potentially expanding the label if successful.

Product differentiation and patient needs

• The oral therapy aims to combine efficacy, safety, and convenience, addressing unmet needs not fully met by current therapies.

• The molecule deucrictibant is a B2 receptor antagonist with a longer half-life than icatibant, enabling both immediate-release (on-demand) and extended-release (prophylactic) formulations.

• Patients can switch between on-demand and prophylactic options as needed, offering flexibility throughout different life stages.

• The company is the only one offering both on-demand and prophylactic oral options, providing unique value to patients and physicians.

• The end of progression is a secondary endpoint in phase III, measuring the first sign the drug is working, which is clinically meaningful and could differentiate the product.

Market opportunity and commercialization

• The oral on-demand market is seen as attractive due to limited innovation in the past decade and patient preference for non-injectable options.

• The prophylactic market is divided between patients preferring injectables and those seeking oral therapies, with recent uptake of oral options highlighting unmet need.

• Commercialization strategy includes a go-it-alone approach in the U.S. and potential partnerships in other territories.

• Two distinct brands will be launched for on-demand and prophylactic products, with packaging designed for convenience and safety.

• A compact commercial footprint is planned, focusing on key physicians, with an estimated 50-person team for the U.S. market.