Announcement of new data for key clinical trial of deucrictibant expected in late 2025

The pharmaceutical company developing a potential new HAE medicine, called deucrictibant, has provided an update on when it will be able to share some new clinical trial data. The company, Pharvaris, expects this announcement will take place in the fourth quarter of 2025. Subject to the data being positive, the company expects to submit a New Drug Application to the US Food and Drug Administration (FDA) in the first half of 2026.

Berndt Modig, Chief Executive Officer of Pharvaris, said: “The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth quarter of this year. Our phase 3 data may provide evidence of immediate-release deucrictibant’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy—from rapid end of progression to fast and complete resolution—and a favorable safety profile, with the convenience of a single-capsule oral dose.”

Peng Lu MD PhD, Chief Medical Officer of Pharvaris, added: “We aim to confirm the findings from our Phase 2 studies in a larger Phase 3 trial, RAPIDe-3. Importantly, this study is assessing the effects of deucrictibant for people with high unmet need beyond adults with HAE type 1 and 2, such as participants with HAE with normal C1 inhibitor and adolescents between 12 and 17 years and will be evaluating the effects of deucrictibant in treating laryngeal attacks. We want to thank the clinical trial participants, the investigators and their study site collaborators for their ongoing commitment to this important trial.”

(Source: Pharvaris)