Trevi Therapeutics, Inc. announced positive results from its Phase 2b/3 Pruritus Relief through Itch-Scratch Modulation trial of Haduvio in treating prurigo nodularis. Trevi Therapeutics Ph2b/3 PRISM trial of Haduvio achieves statistical significance for the treatment of rurigo nodularis is a chronic disease characterized by severe pruritus and the presence of nodules, lesions, and excoriations. Chronic pruritus is a key contributing cause of prurigo nodularis and manifests in an itch-scratch cycle, which is difficult to disrupt.

There are no approved therapies for prurigo nodularis where a large unmet need exists due to its impact on patients' quality of life, function, and emotional well-being. In the Phase 2b/3 PRISM trial, results comparing subjects randomized to Haduvio monotherapy or placebo showed: 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 at 14, which was statistically significant across each of the three domains. ItchyQoL is used to measure how pruritus impacts a subject's quality-of-life. 55% of Haduvio subjects saw at least a 1-category improvement in the 5-point scale in their Prurigo Activity Scale vs.

38% on placebo as evaluated at week 14. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. During the double-blind titration period Treatment-Emergent Adverse Events were more common in the Haduvio-treated subjects vs. placebo-treated subjects.

During the 12-week fixed-dose period, the occurrence of TEAEs were generally similar between Haduvio and placebo groups. Discontinuations during the 14 weeks of the trial were 36.9% in Haduvio-treated subjects vs. 19.3% in placebo-treated subjects.

During the 14-week double-blind portion of the PRISM trial, 8 subjects on Haduvio and 6 subjects on placebo experienced at least one treatment emergent Serious Adverse Event. None of the SAEs were considered by the investigator to be treatment-related. Adverse events most commonly observed with Haduvio were nausea, dizziness, headache, and constipation.