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

Trevi Therapeutics, Inc. 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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