Pharvaris reports fourth quarter and full year 2023 financial results and provides business update

Pharvaris reported financial results for the fourth quarter and year ended 31 December 2023, and provided a business update.

Berndt Modig, Chief Executive Officer of Pharvaris, said: “2024 is off to a strong start, supported by the incredible momentum we built in an impressive 2023—driven by a second positive data readout of deucrictibant that was validated by the support of our investors. At the start of the year, the lift of the remaining hold on the prophylaxis program in the U.S. allowed us to progress with the global Phase 3 clinical development plans for deucrictibant for prevention of HAE attacks. As we move toward the initiation of CHAPTER-3, we hope to realize the promise of the proof-of-concept CHAPTER-1 data, which support deucrictibant’s potential to be a best-in-class oral prophylactic therapy. We are pleased with the HAE community’s excitement in RAPIDe-3, which is enrolling as planned; we will provide the anticipated timing of topline data as enrollment progresses and data is accumulated. Receipt of the Innovation Passport designation for deucrictibant in the UK reflects regulatory recognition of deucrictibant’s innovation for better treatment options for people living with HAE.”

Recent business updates and highlights:

Enrollment initiated in RAPIDe-3 – a global Phase 3 clinical study. Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.

End-of-Phase 2 meeting scheduled to align on prophylactic Phase 3 clinical development plan. Pharvaris continues preparatory activities for CHAPTER-3, a global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks.

Deucrictibant awarded UK Innovation Passport. The UK Innovative Licensing and Access Pathway (ILAP) Steering Group, which consists of the All Wales Therapeutics and Toxicology Centre (AWTTC), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC), has awarded an Innovation Passport to deucrictibant for the on-demand and prophylactic treatment of HAE attacks in people 12 years and older.

Clinical hold lifted. Following review of data from a 26-week rodent toxicology study, the FDA lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the prophylaxis of HAE attacks.

Deucrictibant data presented at recent industry meetings. Data supporting the ongoing development of deucrictibant for both the on-demand and prophylactic treatment of HAE attacks were presented at many international scientific meetings.

(Source: Pharvaris)