Positive Phase 2 Data from RAPIDe-1 Study of PHVS416 for the On-Demand Treatment of HAE Attacks Highlighted at the 2023 HAEi Regional Conference APAC
ZUG, Switzerland, March 18, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: 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.
Dr. Riedl commented, “Currently approved on-demand therapies for HAE attacks are administered intravenously or subcutaneously and can be associated with treatment burden. The 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 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 (either placebo or PHVS416 10, 20, or 30 mg doses). Analysis of the primary endpoint demonstrated that PHVS416 significantly (p<0.0001; nominal p value for 10 mg dose) reduced attack symptoms measured as change in the mean 3-symptom composite (skin pain, skin swelling, abdominal pain) visual analogue scale (VAS-3) score during HAE attacks, at four hours compared with placebo (LS mean difference of change in VAS-3: -16.75, -15.02, and -16.28 for PHVS416 10, 20 and 30 mg, respectively, vs. placebo). All key secondary efficacy endpoints were also met. Participants on PHVS416 also used substantially less rescue medication compared to placebo (10 mg=18.9%, 20 mg=10.7%, 30 mg=6.5%, placebo=60.8%). PHVS416 was generally well tolerated wth three treatment-related adverse events (TRAEs) reported for one PHVS416 30-mg-treated attack (2.8%) and one TRAE reported for one placebo-treated attack (1.9%).
The presentation slides will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations.
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.