Trevi Therapeutics, Inc. (NASDAQ: TRVI) is a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (nalbuphine ER).
Today, Trevi saw its shares leap on the announcement 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.
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.
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 one million patients ex-US, where up to 85% of these patients experience chronic cough.
TRVI shares improved 8.5 cents, or 6.4%, to $1.41.