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

Trevi Therapeutics, Inc. (NASDAQ:TRVI) revealed topline results on Monday from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) (N=165).

The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at week six.

Also Read: Trevi Therapeutics Reveals Positive Data From Mid-Stage Study For Chronic Cough Candidate, Stock Jumps

The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2%, 53.4%, and 47.9%, respectively, compared to a placebo reduction from a baseline of 16.9%. 

At week six, statistically significant improvements were observed across secondary endpoints in the 108 mg BID and 54 mg BID dose groups.

Additional Trial Results

• A rapid reduction was seen in 24-hour cough frequency at week two with Haduvio, the first time point measured.
• A 50% reduction in 24-hour cough frequency at week six versus baseline was seen in 65% of patients on 108 mg BID Haduvio, 63% of patients on 54 mg BID Haduvio and 60% of patients on 27 mg BID Haduvio dose groups, compared to 19% of placebo patients.
• A statistically significant response was observed on the cough-severity numerical rating scale (CS-NRS), a secondary endpoint, at week six on Haduvio in both the 108 mg BID and 54 mg BID dose groups.
• At week six, the mean reduction on a 0 – 10 scale was 3.0 points for the 108 mg BID, 3.2 points for the 54 mg BID and 2.0 points for the 27 mg BID dose groups, compared to a 1.5-point reduction on placebo.
• The 108 mg BID and 54 mg BID dose groups were statistically significant on the patient-reported outcome E-RS: IPF Cough Subscale, a secondary endpoint, with mean relative change from baseline of -42.4% and -43.1%, respectively at week six, compared to -23% for those on placebo at week six.
• The 27 mg BID dose group was not statistically significant with a mean relative change from baseline of –31.6%.

Discontinuation rates due to adverse events were similar in the combined Haduvio (5.6%) and placebo groups (5%).

TRVI Price Action: Trevi stock is down 10.45% at $5.83 at publication on Monday

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