Pharvaris (PHVS) said Tuesday that a global phase 3 study of deucrictibant extended-release tablets met the primary endpoint of reducing the mean monthly attack rate by 83%, compared with placebo, in people with hereditary angioedema.
The primary endpoint and all secondary efficacy endpoints met statistical significance, the company said.
Among participants with HAE Type 1 or Type 2, the mean monthly attack rate was 87% lower with deucrictibant XR versus placebo, while protection began within the first week and was sustained through the 24 weeks of study treatment, the company said.
Deucrictibant XR was well tolerated, with most treatment-emergent adverse events mild or moderate and no treatment-related serious adverse events reported.
Pharvaris plans to submit a new drug application to the US Food and Drug Administration for prophylaxis of bradykinin-mediated angioedema attacks in H1 2027.
Shares of the company were over 24% higher in premarket activity Tuesday.
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