Trevi Therapeutics, Inc. (Nasdaq: TRVI) is a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions. Today, Trevi announced that it has completed enrollment in its Phase 2b/3 PRISM trial for pruritus associated with prurigo nodularis (PN) and expects to report top-line data in the second quarter of 2022.
“We are pleased to have completed enrollment in our Phase 2b/3 PRISM trial and look forward to reporting top-line data in the second quarter of this year,” said Jennifer Good, Trevi Therapeutics President and CEO. “This is an important milestone in the development of Haduvio which is the lead oral compound in clinical development for pruritus in PN and which we believe may offer an important treatment option to these seriously impacted patients. By targeting the pruritus associated with prurigo nodularis, Haduvio is designed to break the itch-scratch cycle which has a significant impact on patients’ quality of life. We look forward to seeing these results and advancing the development of Haduvio to address the unmet need of patients with pruritus across conditions.”
The PRISM trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Haduvio for severe pruritus in patients with PN. In the trial, subjects are randomized equally across two treatment groups (oral Haduvio 162 mg or placebo, twice daily including an initial 2-week blinded titration period). The primary endpoint of the trial is the proportion of subjects achieving a greater than or equal to 4-point improvement in the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14 compared to baseline. The planned enrollment for the trial was approximately 360 subjects.
The Company previously announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation of nalbuphine ER for the proposed indication of reduction of moderate to severe pruritus in patients with PN. Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.