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Trevi Therapeutics Inc. on Tuesday announced it has concluded enrollment early for its Phase 2 trial for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis, citing positive results.
The New Haven-based clinical-stage biopharmaceutical company is developing an investigational therapy called Haduvio, or nalbuphine ER.
The announcement comes about a month after the company reported statistically significant results in the trial. Company leaders at the time indicated they planned to stop recruiting patients due to the “strength and consistency” of the data.
According to Trevi, interim results showed a 77.3% reduction in daytime cough frequency from baseline with the use of Haduvio compared to a 25.7% reduction with a placebo.
Trial sites have been notified that they can enroll eligible subjects already in screening but no additional recruitment is required. Approximately 40 subjects have been enrolled in the study.
Trevi indicated it anticipates reporting efficacy and safety results on all the subjects in the third quarter of this year.
According to the company, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) is a serious complication of a terminal disease, with no approved therapies currently. Trevi estimates there are 130,000 patients in the United States suffering from IPF, and about 85% of them have a chronic cough.
Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.
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