Pharvaris announces dosing of the first patient in RAPIDe-1, an on-demand Phase 2 study evaluating the efficacy, safety, and pharmacokinetics of PHVS416 in patients with HAE due to C1-Inhibitor Deficiency type 1 and 2.
“The initiation of this trial signifies another step towards developing an oral treatment for HAE patients experiencing acute attacks,” says Berndt Modig, CEO and co-founder of Pharvaris. “The importance of providing patients with treatment alternatives to injection cannot be overstated. We hope to confirm in HAE patients the compelling findings of our previous studies. This study will help to determine if our small-dosage oral softgel capsule provides safe, rapid, and convenient on-demand treatment of HAE attacks.”
RAPIDe-1 is a Phase 2 study evaluating the efficacy and safety of orally administered PHVS416 for the acute treatment of attacks in patients with HAE type 1 or 2. The study aims to enroll 54 adults, ages 18 to 75, at centers in North America and Europe. Eligible patients are randomized to one of three single doses of active and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of PHVS416 with placebo. PHVS416 is a softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor.