Trevi Therapeutics IncTRVI announced results from the full set of subjects in its Phase 2 CANAL trial of Haduvio for treating chronic cough in idiopathic pulmonary fibrosis (IPF).
Following the statistically significant efficacy results from interim analysis (N=26) conducted in February 2022, the company concluded enrollment early in March 2022.
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, with a 75.1% reduction in daytime cough frequency.
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.
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.
Key secondary endpoints on patient and clinician-reported outcomes were also statistically significant.
The company plans to start its subsequent clinical trial in chronic cough patients in the first half of 2023.
Price Action: TRVI shares are up 1.23% at $3.30 on the last check Monday.
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