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Enrollment Concludes for New Trial in Chronic Cough

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Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (nalbuphine ER). Today, Trevi announced that it concluded enrollment early for its Phase 2 Cough And NALbuphine (CANAL) trial for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) patients following the previously announced statistically significant efficacy results from the interim analysis (N=26). The primary efficacy endpoint demonstrated a 77.3% reduction in daytime cough frequency from baseline with the use of Haduvio compared to a 25.7% reduction with placebo, demonstrating a 52% placebo-adjusted reduction in the geometric mean percent change in the daytime cough frequency (p<0.0001).

Because the trial achieved statistical significance in the interim analysis, sites were notified that they could enroll eligible subjects already in screening but that no additional recruitment was required. Approximately 40 subjects in total have been enrolled in the study. The Company continues to expect to report efficacy and safety on the full set of subjects in the third quarter of 2022.

IPF is a serious, end of life disease where cough is one of the most significant symptoms. There are estimated to be 130,000 IPF patients in the US and more than 1 million patients ex-US, where up to 85% of these patients experience chronic cough. There are no approved therapies for the treatment of chronic cough in IPF, and the cough is often refractory to antitussive therapy. Patients with chronic cough in IPF can cough up to 520 times per day, leading to increased feelings of anxiety as it induces breathlessness. Coughing spells or episodes lead to significant fatigue, air hunger, peripheral oxygen desaturation and some patients also experience cough-related urinary incontinence. The social impact of chronic cough in IPF further compounds limited exercise ability, reduced walking distance and the need to use supplemental oxygen. The chronic cough in IPF may be an early clinical marker of disease activity, identify patients at high risk of progression, predict time to death or lung transplant, and may also contribute to enhanced activation of profibrotic mechanisms and disease worsening in IPF.

About the author


Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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