Pharvaris phase 3 HAE results for deucrictibant published in The Lancet
Pharvaris said its Phase 3 RAPIDe-3 trial of oral deucrictibant immediate-release capsules for hereditary angioedema attacks was published in The Lancet. The 20 mg on-demand treatment reached the main outcome and each of its 11 secondary measures, outperforming placebo on symptom relief and full resolution. Pharvaris reported symptom relief after 1.28 hours and complete resolution after 11.95 hours, with no observed safety signals.
Why it matters
The publication adds peer-reviewed support for Pharvaris' regulatory submissions for deucrictibant IR. The company has applications pending before U.S. and European regulators, and the FDA's action deadline is April 23, 2027.
Key facts
- 1RAPIDe-3 evaluated a 20 mg oral immediate-release deucrictibant capsule for treating HAE attacks as needed in adolescents and adults. globenewswire.com
- 2Pharvaris reported a 1.28 hours time to symptom relief and 11.95 hours to complete symptom resolution with deucrictibant IR. globenewswire.com
- 3The Phase 3 trial achieved its primary measure plus all 11 secondary measures. globenewswire.com
- 4Pharvaris said no safety signals emerged in the study. globenewswire.com
- 5The FDA has set April 23, 2027 as the PDUFA action date for the deucrictibant IR application. globenewswire.com
- 6The European Medicines Agency is reviewing Pharvaris' marketing authorization application for deucrictibant IR. globenewswire.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.