Trevi Therapeutics resumes patient screening for Phase 2 trial of Haduvio

Trevi Therapeutics announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis, a trial that was paused due to IPF patients being an at-risk population for COVID-19. In addition, the Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis, randomized its 180th subject, officially reaching 50% enrollment. Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis: The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in patients with IPF that is being conducted in the United Kingdom. The study is designed to enroll approximately 60 subjects with a goal to have 44 study completers. The primary endpoint for the study is the mean percent change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints. The amended protocol was recently approved by the Medicines and Healthcare products Regulatory Agency of the UK and patient screening has restarted at certain sites in the UK. Additionally, Trevi is analyzing the possible addition of study sites in Germany to potentially accelerate enrollment and mitigate the COVID-related risks inherent to recruitment from a single-country. Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: During October, the PRISM trial randomized its 180th subject into the study, reaching 50% enrollment of the expanded trial size following the sample size re-estimation completed in July. We expect to complete enrollment in the PRISM trial in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.