Upon the release of positive results from its phase 3 CHAPTER-3 study, Pharvaris has announced that it will be submitting marketing authorizations for deucrictibant extended-release (XR) tablets in the first half of 2027.
Deucrictibant XR is a prophylactic treatment hereditary angioedema (HAE) attacks. The novel, potent, orally-available small-molecule bradykinin B2 receptor antagonist is currently in studies to investigate its potential to prevent bradykinin-mediated angioedema attacks and to treat the manifestations of the attacks.
The CHAPTER-3 trial of deucrictibant XR was the first to study prophylaxis of all three types of HAE. The drug met its primary endpoint, reducing the mean monthly attack rate by 83% compared to the placebo, including an 87% reduction in attack rates in people with HAE Type 1 and 2. It also met its secondary efficacy endpoints and was well tolerated.
Pharvaris has also developed deucrictibant IR, an immediate-release capsule for on-demand treatment. In July, the FDA accepted an NDA for deucrictibant IR capsules to treat HAE attacks, with a PDUFA action date set for April 23, 2027. This came shortly after the agency granted approval for Ekterly, a novel plasma kaillikrein inhibitor from KalVista Pharmaceuticals, which also treats acute attacks of HAE.