Pharvaris to report phase 3 data and submit New Drug Application
Ella Day | July 15, 2025 | News story | Medical Communications, Research and Development | Pharvaris, Rare Diseases, US Food and Drug Administration, clinical trial, genetic condition, new drug application
Pharvaris has announced that its data from its phase 3 study of deucrictibant immediate-release capsules (IR) for the treatment of hereditary angioedema (HAE) attacks will now be released in the fourth quarter of 2025. Pending positive results, the company expects to submit a New Drug Application to the US Food and Drug Administration in the first half of 2026.
The RAPIDe-3 trial is evaluating deucrictibant, an oral bradykinin B2 receptor antagonist, in approximately 120 people living with HAE, including those with normal C1 inhibitor. The study’s primary endpoint is time to onset of symptom relief, with secondary endpoints including complete symptom resolution and safety measures.
“Our phase 3 data may provide evidence of deucrictibant IR’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy and a favourable safety profile, with the convenience of a single-capsule oral dose,” said Berndt Modig, CEO of Pharvaris.
The trial is also assessing the treatment’s effect on laryngeal attacks in younger patients aged 12 to 17 years. HAE is a rare genetic condition that involves recurrent attacks of severe swelling in various parts of the body. Swelling in the airway can restrict breathing and be life-threatening.
Deucrictibant has already been granted orphan drug status in the US and Europe. It is being developed in two formulations for both prophylactic and on-demand treatment of bradykinin-mediated angioedema.
Ella Day
15/7/25
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