Promising data from the phase 2 RAPIDe-1 study of PHVS416 for the on-demand treatment of hereditary angioedema (HAE) attacks were presented by Pharvaris at the 2023 HAEi Regional Conference APAC in Bangkok, Thailand.
The RAPIDe-1, phase 2, double-blind, placebo-controlled, randomized, cross-over, dose-ranging trial of PHVS416 gathered 74 participants from Canada, Europe, Israel, the United Kingdom, and the United States. Eligible participants were patients with HAE type 1 or 2 between the ages of 18 and 75 years who experienced 3 or more attacks in the last 4 months or 2 or more attacks in the last 2 months prior to screening.
During the study, 62 patients experienced 147 qualifying HAE attacks that were treated with placebo or 10, 20, or 30 mg of PHVS416.
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“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,” said Marc Riedl, MD, MS, clinical director of the US Hereditary Angioedema Association Angioedema Center and clinical service chief for allergy/immunology at the University of California San Diego, who delivered the presentation.
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According to the results, PHVS416 significantly decreased HAE attack symptoms at 4 hours compared with placebo, as evidenced by a change in the mean 3-symptom composite (skin pain, skin swelling, abdominal pain) visual analog scale score during HAE attacks. Patients receiving the novel medication also used substantially less rescue medication compared with the control group.
PHVS416 was generally well tolerated in the study. There were 3 reports of treatment-related adverse events after receiving a 30 mg dose of PHVS416, and 1 occurrence of treatment-related adverse events in the placebo group.
The novel medication is produced in the oral soft gel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor, used to provide rapid symptom relief during HAE type 1 and 2 attacks.
Reference
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. News release. Pharvaris NV; March 18, 2023.
