Pharvaris announced promising results from the RAPIDe-1 phase 2 clinical study of PHVS416 as an oral on-demand treatment for hereditary angioedema (HAE) attacks in patients with type 1 or 2 HAE.

RAPIDe-1 phase 2 is designed as a double-blind, placebo-controlled, randomized, crossover, dose-ranging study meant to compare symptom relief during HAE attacks and the safety of each dose of PHVS416 soft gel capsule with placebo. It gathers 74 patients from 13 countries who were randomly assigned into groups receiving placebo, or 10, 20, and 30 mg of PHVS416.

Phase 1 of the study investigated the pharmacokinetics and safety of the medication by treating participants in a nonattack state with the assigned single dose of PHVS416 at the study center. In phase 2, the researchers asked participants to self-administer a blinded study drug at home to treat 3 physician-confirmed HAE attacks with PHVS416 or placebo.


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The study authors were primarily assessing changes in skin pain, skin swelling, and abdominal pain from pretreatment to 4 hours after the treatment. The results gathered from 147 attacks in 62 patients indicate that PHVS416 significantly reduces attack symptoms.

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“The data demonstrate rapid onset of action, symptom relief, and resolution of attacks, which support the further development of PHVS416 as a potential on-demand therapy for HAE. Further, study participants used substantially less rescue medication when taking PHVS416 to treat attacks versus when treating with placebo. The strength and durability of effect shown in the top-line data from RAPIDe-1, as well as the observed safety profile, has further enhanced our confidence in the clinical development strategy,” Peng Lu, MD, PhD, chief medical officer of Pharvaris noted.

Reference

Pharvaris announces positive top-line phase 2 data from RAPIDe-1 study of PHVS416 for the on-demand treatment of HAE attacks. News release. Pharvaris N.V.; December 8, 2022.