Pharvaris says Lancet published phase 3 deucrictibant data

• RAPIDe-3 met its primary endpoint and all 11 secondary endpoints, according to Pharvaris.
• The company said symptom relief came in 1,28 jam and complete symptom resolution in 11,95 jam.
• The FDA and EMA are reviewing applications for deucrictibant IR for on-demand HAE treatment.

Pharvaris said results from its RAPIDe-3 phase 3 study have been published in The Lancet. The company said the oral deucrictibant immediate-release capsule is under review by regulators for on-demand treatment of hereditary angioedema attacks.

Pharvaris says Lancet published phase 3 deucrictibant data

The study evaluated a 20 mg capsule in adolescents and adults in a global, randomized, double-blind, placebo-controlled crossover design. Pharvaris said the treatment led to faster onset of symptom relief and faster complete symptom resolution than placebo.

Study results

Pharvaris said deucrictibant IR produced a faster time to onset of symptom relief, at 1.28 hours, and to complete symptom resolution, at 11.95 hours. It said the treatment was well tolerated and no safety signals were observed.

The company said RAPIDe-3 met its primary endpoint and all 11 secondary endpoints with high statistical significance. It added that most attacks were adequately controlled with a single capsule.

Results were consistent across subgroups defined by age, geographic location, HAE type, use of long-term prophylaxis, and attack severity and location, including non-severe laryngeal attacks, the company said.

Regulatory review

Pharvaris said a New Drug Application for deucrictibant IR is under review by the U.S. Food and Drug Administration, with a PDUFA target action date of April 23, 2027. It also said a Marketing Authorization Application is under review by the European Medicines Agency.

Marc A. Riedl, the principal RAPIDe-3 study investigator and lead author, said bradykinin B2 receptor antagonism is a validated and reliable mechanism and that the study showed deucrictibant IR rapidly ended attack progression and accelerated complete symptom resolution.

Peng Lu, president of Pharvaris, said the results across subgroups underscore the clinical relevance of antagonizing the bradykinin B2 receptor. He said the findings are the first pivotal step in the company’s broader clinical development strategy.