Pharvaris: Topline data of pivotal Phase 3 for angioedema attacks treatment

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), updated the guidance for the disclosure of topline data from the ongoing RAPIDe-3 pivotal Phase 3 study evaluating deucrictibant immediate-release (IR) capsule for the on-demand treatment of HAE attacks. Pharvaris anticipates announcing topline data from RAPIDe-3 in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026.

“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,” said Berndt Modig, Chief Executive Officer of Pharvaris. “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—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, M.D., Ph.D., 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.”

RAPIDe-3 (NCT06343779) is a global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of angioedema attacks in approximately 120 adult and adolescent (12 years and older) participants with HAE, including forms with C1 inhibitor deficiency and forms with normal C1INH. The primary endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least “a little better.” Other endpoints include time to End of Progression (EoP) in attack symptoms, substantial symptom relief, complete symptom resolution and proportion of complete symptom resolution achieved with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S), PGI-C, and by Angioedema Symptom Rating Scale (AMRA), and incidence of treatment-emergent adverse events (TEAEs).

About Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration and orphan designation by the European Commission.