Pharvaris reports positive CHAPTER-3 Phase 3 data for deucrictibant XR in HAE prophylaxis

Pharvaris N.V. released topline results from its CHAPTER-3 Phase 3 trial on September 8, 2026, evaluating deucrictibant extended-release (XR) tablets as long-term prophylaxis for hereditary angioedema (HAE). The study was the first pivotal trial in prophylaxis to include all types of HAE, enrolling 85 participants aged 12 and above with HAE Type 1/2 and HAE-nC1INH (Type 3), randomized 2:1 to deucrictibant XR 40 mg once daily or placebo over a 24-week treatment period.¹

On the primary endpoint, deucrictibant XR produced an 83% reduction in attack rate versus placebo (95% CI: 72-90%, p<0.0001), with an 87% reduction in the HAE Type 1/2 subgroup (n=80).¹ The company noted this subgroup finding was an additional analysis of HAE Type 1/2, not adjusted for multiplicity.¹

The company said all secondary efficacy endpoints met statistical significance, with early-onset protection within one week that was sustained throughout the study, and no treatment-related serious adverse events reported.¹ On quality of life, the AE-QoL total score change from baseline showed a least-squares mean difference of -23.53 versus placebo (95% CI: -32.15 to -14.92, p<0.0001).¹

Safety data showed treatment-emergent adverse events occurred in 76.4% of the XR group versus 56.7% on placebo, with one serious adverse event (1.8%) in the XR arm and none in placebo; drug discontinuation due to TEAEs occurred in 1.8% of the XR group and 3.3% of placebo.¹

Pharvaris outlined near-term milestones including an FDA PDUFA goal date of April 23, 2027 for the on-demand treatment, CREAATE Phase 3 Part 1 data expected in the first quarter of 2027, and a U.S. NDA submission for the long-term prophylaxis indication planned for the first half of 2027.¹