- Trevi Therapeutics Inc (NASDAQ:TRVI) has announced positive results from its Phase 2b/3 PRISM trial of Haduvio in treating prurigo nodularis, a chronic disease characterized by severe pruritus and the presence of nodules, lesions, and excoriations.
- In the trial, results comparing subjects randomized to Haduvio monotherapy (n=168) or placebo (n=176) showed that 25% of Haduvio subjects evaluated at week 14 met the primary endpoint of a 4-point reduction in WI-NRS from baseline compared to 14% of placebo subjects.
- Haduvio subjects experienced significantly greater improvements in ItchyQoL vs. placebo.
- 55% of Haduvio subjects saw at least a 1-category improvement in the 5-point scale in their Prurigo Activity Scale (PAS) (pruriginous lesions with excoriations), vs. 38% on placebo.
- The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials.
- Earlier this year, the company reported encouraging interim data from the Phase 2 CANAL trial of Haduvio in idiopathic pulmonary fibrosis patients suffering from chronic cough.
- Price Action: TRVI shares are up 36.6% at $2.76 during the premarket session on the last check Wednesday.
