Trevi Therapeutics, Inc. announced positive results from the full set of subjects in its Phase 2 Cough And NALbuphine (CANAL) trial of Haduvio for the treatment of chronic cough in IPF. Dr. William Forbes will present the data during the Company's Virtual R&D Day on September 19 from 10 AM-11:45 AM ET. Following the statistically significant efficacy results from the CANAL trial's interim analysis (N=26) conducted in February 2022, the Company concluded enrollment early in March 2022 and allowed enrolled subjects to complete the trial.

Topline data from the full set of subjects (N=38) in the Phase 2 CANAL trial was statistically significant for the trial's primary endpoint and showed a 52.5% change compared to placebo (p<0.0001), with a 75.1% reduction in the geometric mean percent change in daytime cough frequency for Haduvio. Additional Efficacy Analyses: Haduvio subjects had a 76.1% reduction in 24hr cough frequency compared to a 25.3% of placebo subjects, a 50.8% placebo-adjusted change (p<0.0001). In a post-hoc analysis, 97% of Haduvio subjects had at least a 30% reduction in 24hr cough frequency compared to 35% of placebo subjects, signifying a clinically meaningful reduction in cough (p<0.0001).

Subjects on Haduvio experienced a statistically significant improvement as measured by their patient reported outcomes compared to placebo over the 3-week treatment period in the EXACT2: Cough Frequency Score (p=0.001) and Cough Severity Numerical Rating Scale (p=0.0001). Based on the Clinical Global Impression of Change rating measuring clinicians' view of change since the start of the trial, 62% of Haduvio subjects improved vs. baseline compared to 19% of placebo subjects (p=0.01).

Safety and Tolerability Results: The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. There were two serious adverse events reported during the trial, neither of which was considered by the investigator to be treatment related. Adverse events most commonly observed during the trial were nausea, fatigue, constipation, dizziness, somnolence, vomiting, headache, anxiety and depression.