ZUG, Switzerland, November 10, 2025 — Pharvaris N.V. (Nasdaq: PHVS), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists, announced new data at the ACAAI 2025 Annual Scientific Meeting demonstrating the long-term safety, sustained efficacy, and potential differentiation of its lead candidate, deucrictibant, in patients with Hereditary Angioedema (HAE). The findings underscore the therapeutic’s potential to provide durable prophylactic and on-demand control of bradykinin-mediated angioedema, a condition marked by unpredictable and potentially life-threatening swelling attacks.
Science Significance
Pharvaris’ data from multiple oral presentations and six posters provide robust evidence of deucrictibant’s clinical potential, showing sustained benefits across both prophylaxis and acute treatment settings. In the CHAPTER-1 open-label extension, patients maintained a 92.4% reduction in attack frequency for up to 34 months, confirming long-term efficacy and tolerability. Complementary data from the RAPIDe-2 extension study revealed rapid symptom resolution within 1.1 hours for most on-demand treatments, with nearly 90% of attacks resolving within 24 hours after a single oral dose. Additionally, the kinin biomarker assay developed by Pharvaris demonstrated clinical validation, marking a significant advance in the ability to characterize bradykinin-mediated diseases and personalize therapy.
Regulatory Significance
Deucrictibant has received Orphan Drug Designation from the U.S. FDA, Swissmedic, and the European Commission, highlighting its relevance in addressing an unmet rare disease need. The data presented reinforce the molecule’s regulatory momentum ahead of pivotal Phase 3 studies—CHAPTER-3 for prophylactic use and RAPIDe-3 for on-demand treatment—expected to define its clinical and safety benchmarks for global submissions. Pharvaris’ validated biomarker assay could further strengthen regulatory evaluation by offering a quantifiable measure of bradykinin pathway activity, improving clinical endpoints and regulatory confidence in efficacy outcomes.
Business Significance
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The positive long-term safety and efficacy profile of deucrictibant strategically positions Pharvaris within the competitive angioedema therapeutics market, currently dominated by injectable biologics. The company’s oral formulations—extended-release for prophylaxis and immediate-release for acute attacks—promise a major commercial advantage through ease of administration and patient preference. With Phase 3 data readouts anticipated in 2026, Pharvaris is poised to enter a multi-billion-dollar rare disease market, aligning with its goal to deliver injectable-like efficacy with placebo-like tolerability in an oral format. These data strengthen investor confidence and may catalyze strategic partnerships or licensing deals ahead of commercialization.
Patients’ Significance
For individuals living with Hereditary Angioedema, deucrictibant represents a potential paradigm shift—offering the first fully oral treatment option capable of both preventing and rapidly resolving HAE attacks. The sustained safety profile and improvements in health-related quality of life (HRQoL) observed in the CHAPTER-1 study highlight the therapy’s transformative potential. Patients could experience greater independence, reduced disease burden, and fewer disruptions in daily activities, improving adherence and long-term outcomes. Moreover, the therapy’s durable control and fast onset of action may mitigate the emotional distress and healthcare costs associated with recurrent hospitalizations.
Policy Significance
The development of deucrictibant underscores the growing importance of orphan drug innovation, rare disease incentives, and precision biomarker integration within regulatory and reimbursement frameworks. As global healthcare systems emphasize value-based approvals and patient-centered outcomes, Pharvaris’ approach—combining biomarker validation with long-term safety data—sets a precedent for evidence-driven rare disease therapeutics. Policymakers and payers are likely to view deucrictibant as a model of accessible innovation, especially as it aligns with priorities around oral, self-administered treatments that reduce the burden on specialized infusion infrastructure.
Pharvaris’ expanded dataset at ACAAI 2025 positions deucrictibant as one of the most advanced oral therapies in the HAE pipeline, combining clinical robustness with patient convenience. As the company advances toward pivotal Phase 3 milestones, its integrated strategy—anchored in scientific rigor, regulatory foresight, and patient-centered innovation—could redefine the standard of care for bradykinin-mediated angioedema. The sustained efficacy and biomarker-backed precision of deucrictibant signal a future where orally administered, well-tolerated rare disease therapies become a clinical reality.
Source: Pharvaris N.V. press release
