Pharvaris Unveils RAPIDe-3 Phase 3 Study and HAE Quality-of-Life Data

Swiss biopharmaceutical firm Pharvaris has launched a Phase 3 clinical trial called RAPIDe-3 to test the efficacy and safety of its immediate-release capsule, deucrictibant (PHVS416), for treating hereditary angioedema (HAE) attacks. The company, which is listed on the Nasdaq under the ticker PHVS, has been actively participating in recent events, including the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) and the 2024 HAE International (HAEi) Regional Conference Americas.

Berndt Modig, Pharvaris' CEO, emphasized the company's dedication to advancing deucrictibant's clinical development to meet the current treatment gaps in HAE management. The company is working closely with regulatory bodies to ensure a comprehensive study that evaluates the drug's performance and safety. Modig expressed confidence in deucrictibant's potential to be a leading option for both preventing and treating HAE attacks.

Peng Lu, Pharvaris' Chief Medical Officer, highlighted the HAE community's need for a quick-acting, easy-to-take oral medication that can fully resolve angioedema attacks. The RAPIDe-3 study aims to determine whether deucrictibant meets this need. Pharvaris claims to be the pioneer in incorporating the 'End of Progression' endpoint into a pivotal trial, a measure recognized by HAE patients and doctors that indicates when symptoms stop worsening. This could set deucrictibant apart from other treatments.

The Phase 3 RAPIDe-3 trial's design was unveiled through two posters. One, presented by Mauro Cancian, M.D., Ph.D., at ITACA, and the other by Anete Grumach, M.D., Ph.D., at the HAEi Americas Congress, detailed the trial's structure. The study will involve approximately 120 participants globally and will be a randomized, double-blind, placebo-controlled, crossover trial. The primary goal is to measure the time to symptom relief, with other endpoints focusing on the time to symptom progression cessation and the proportion of attacks resolved with a single dose.

Additionally, Andrea Zanichelli, M.D., Ph.D., presented data from the CHAPTER-1 study, demonstrating that oral deucrictibant's prophylactic treatment improves health-related quality of life (HRQoL) for HAE patients, alongside a significant reduction in attack frequency.

Deucrictibant is an oral antagonist of the bradykinin B2 receptor, designed to treat HAE attack symptoms and prevent attacks. Pharvaris is developing two forms of the drug: a rapid-onset capsule for acute treatment and an extended-release tablet for prophylactic use.

Pharvaris is a late-stage biopharmaceutical company with a focus on HAE, aiming to provide efficacious, safe, and easy-to-administer treatments for all HAE subtypes. The company's team consists of industry experts with extensive knowledge in rare diseases and HAE.