Trevi Therapeutics Showcases Drug That Cuts Cough Frequency In Lung Disease Patients

Trevi Therapeutics (TRVI) announced positive topline results from its Phase 2b CORAL trial of Haduvio for chronic cough in IPF patients, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at week six compared to placebo; specifically, 65% of patients on the 108 mg BID dose saw a 50% drop in cough frequency versus 19% on placebo. Statistically significant improvements were also observed in secondary endpoints for the 108 mg BID and 54 mg BID dose groups, however, Trevi stock is down 10.45% at $5.83 at publication on Monday.

Analysis

Trevi Therapeutics (TRVI) reported positive topline results from its Phase 2b CORAL trial for Haduvio in treating chronic cough in idiopathic pulmonary fibrosis (IPF) patients, successfully meeting the primary endpoint with statistically significant reductions in 24-hour cough frequency across all dose groups at week six. Specifically, the 108 mg BID dose group demonstrated a 60.2% reduction from baseline compared to 16.9% for placebo, with 65% of patients on this dose achieving a 50% reduction in cough frequency versus 19% on placebo. The 54 mg BID dose also exhibited strong efficacy, achieving a 53.4% mean reduction in cough frequency. Statistically significant improvements were also observed in key secondary endpoints for the 108 mg BID and 54 mg BID dose groups, including the cough-severity numerical rating scale (CS-NRS), where the 54 mg BID dose led to a mean 3.2-point reduction compared to a 1.5-point reduction for placebo, and the patient-reported E-RS: IPF Cough Subscale which showed mean relative changes from baseline of -42.4% (108mg BID) and -43.1% (54mg BID) compared to -23% for placebo. The 27 mg BID dose, while meeting the primary endpoint, was not statistically significant on the E-RS: IPF Cough Subscale. Importantly, discontinuation rates due to adverse events were similar between the combined Haduvio groups (5.6%) and the placebo group (5.0%), indicating a generally well-tolerated profile. Despite these clinically favorable outcomes, Trevi Therapeutics' stock price declined 10.45% to $5.83 at the time of the announcement.

Key Decisions for Investors

• Investors should carefully analyze the discrepancy between Haduvio's positive Phase 2b CORAL trial data and TRVI's subsequent stock price decrease of 10.45%.
• The robust efficacy demonstrated by Haduvio, particularly at the 108 mg and 54 mg BID dosages in reducing cough frequency and improving secondary outcomes alongside a favorable safety profile, warrants close attention for its market potential in IPF-related chronic cough.
• Monitor upcoming company disclosures regarding Phase 3 trial design, timelines, and engagement with regulatory authorities, as these will be critical catalysts for TRVI.
• Consider the current valuation of TRVI in light of the positive clinical results versus the recent market reaction, assessing if a potential dislocation presents an opportunity or reflects unarticulated risks.