Peng Lu, MD, PhD, Chief Medical Officer at Pharvaris, and Wim Souverijns, PhD, Chief Commercial Officer at Pharvaris, discuss the RAPIDe-3 clinical trial of deucrictibant for patients with hereditary angioedema (HAE).
Hereditary angioedema (HAE) is a rare condition characterized by recurrent episodes of severe swelling of the skin and mucous membranes. These attacks generally become more frequent after puberty, and continue throughout life, often affecting the skin, gastrointestinal tract, and upper airway. Triggers for these episodic HAE attacks vary but may include emotional stress, physical stress, and dental procedures. HAE may be caused by genetic changes in the SERPING1 gene (also called the C1NH gene) or in the F12 gene. In some cases, the genetic cause is not yet certain.
Deucrictibant is a potent, selective, orally administered antagonist of the bradykinin B2 receptor being developed for prophylactic and on-demand treatment of bradykinin-mediated HAE attacks. RAPIDe-3 (NCT06343779) is a phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of oral deucrictibant immediate-release (IR) capsule for on-demand treatment of HAE attacks.
Target enrollment of 120 participants was achieved. The primary endpoint is time to onset of symptom relief, defined as a Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Secondary endpoints include proportion of attacks achieving onset of symptom relief, and time to substantial symptom relief, reduction in attack severity, complete attack resolution, and end of progression of attack symptoms. Other secondary endpoints are rescue medication use and the proportion of attacks achieving complete attack resolution (including with a single dose). Safety outcomes include treatment-emergent adverse events. For more information about the clinical trial, visit ClinicalTrials.gov
As Dr. Lu mentions, top-line data is expected to be presented in the fourth quarter of 2026 with the goal of approval in the first half of 2027.
To learn more about HAE and other rare genetic conditions, visit https://checkrare.com/diseases/congenital-and-genetic-conditions/