Positive Phase 2 Data from RAPIDe-1 Study of PHVS416 for the On-Demand Treatment… – Press Release


ZUG, Switzerland, March 18, 2023 (GLOBE NEWSWIRE) — Pharvaris PHVS, a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced an oral presentation of positive data from its Phase 2 RAPIDe-1 study of PHVS416 for the on-demand treatment of attacks at the 2023 HAEi Regional Conference APAC, taking place in Bangkok, Thailand, on March 17-19, 2023.

Presentation Details

  • Title: Efficacy and Safety of Bradykinin B2 Receptor Inhibition with Oral PHVS416 in Treating Hereditary Angioedema Attacks: Results of RAPIDe-1 Phase 2 Trial
  • Presenter: Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the US Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California San Diego (UCSD), and Clinical Service Chief for Allergy/Immunology at UCSD
  • Date, Time: Saturday, March 18, 11:35 a.m. ICT (12:35 a.m. EDT)

Dr. Riedl commented, “Currently approved on-demand therapies for HAE attacks are administered intravenously or subcutaneously and can be associated with treatment burden.┬áThe time required for preparation and administration, as well as potential occurrence of pain, discomfort, or other injection site reactions can lead to treatment delays or untreated HAE symptoms. An unmet need exists for on-demand oral therapies that are effective and well-tolerated, and that may reduce the treatment burden, enabling prompt administration as recommended by clinical guidelines. The consistent results across all endpoints in the RAPIDe-1 trial provide evidence supporting the efficacy and well-tolerated profile of PHVS416 in treating HAE attacks and provide a foundation for its further development as a potential on-demand therapy.”

RAPIDe-1 is a Phase 2, double-blind, placebo-controlled, randomized, cross-over, dose-ranging trial of PHVS416, the oral softgel capsule formulation of PHA121, for the treatment of HAE type 1 and type 2 (HAE-1/2) attacks. The…