Pharvaris announces Phase 2 data from RAPIDe-1 Study of PHVS416

Pharvaris announced an oral presentation of 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. 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 attacks. The trial enrolled participants in Canada, Europe, Israel, the United Kingdom, and the United States. Eligible participants were between the ages of 18 and 75 years, diagnosed with HAE type I or II and experienced three or more attacks in the last four months or two or more attacks in the last two months prior to screening. 74 participants were enrolled and 62 of them experienced 147 qualifying HAE attacks that were treated with double-blinded study drug. Analysis of the primary endpoint demonstrated that PHVS416 significantly reduced attack symptoms measured as change in the mean 3-symptom composite visual analogue scale score during HAE attacks, at four hours compared with placebo. All key secondary efficacy endpoints were also met. Participants on PHVS416 also used substantially less rescue medication compared to placebo. PHVS416 was generally well tolerated with three treatment-related adverse events reported for one PHVS416 30-mg-treated attack and one TRAE reported for one placebo-treated attack.