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February 25, 2022

Trevi reports encouraging results in chronic cough drug trial

PHOTO | CONTRIBUTED Trevi Therapeutics CEO Jennifer Good
By Michelle Tuccitto Sullo

Trevi Therapeutics Inc. on Thursday announced positive results in its Phase 2 trial of the investigational drug Haduvio in patients with idiopathic pulmonary fibrosis who are suffering from chronic cough.

The New Haven-based biopharmaceutical company also indicated it will stop recruiting patients in the trial due to the “strength and consistency of the data.” Trevi said it would focus on advancing Haduvio into the next phase of development.

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 to help treat it. Trevi estimates there are 130,000 patients in the United States suffering from IPF, and a large percentage — roughly 85% — have a chronic cough.

The company indicated the interim results showed “statistically significant” efficacy for cough reduction. According to the study, daytime cough frequency following treatment dipped by 77% with Haduvio, compared to 25% with a placebo. Trevi now plans to accelerate development of Haduvio, also called nalbuphine ER, and initiate discussions with health authorities regarding next steps.

Dr. Bill Forbes, chief development officer at Trevi, said the company is excited about the results and potential to treat chronic cough in these patients.

“Based on these significant results and consistency of the data, we are ending recruitment into the CANAL trial to focus on accelerating Haduvio into the next phase of development,” Forbes said.

Dr. Toby Maher, professor of medicine and director of interstitial lung disease at Keck School of Medicine, University of Southern California, called the results “extremely encouraging.”

Chronic cough can be particularly debilitating for these patients, according to Maher.

“Chronic cough in IPF is unusually challenging as it is often refractory to antitussive medications and is typically not modified by currently approved anti-fibrotic therapies,” Maher said. “Chronic cough is a frequent symptom affecting IPF patients which contributes to emotional, physical and psychological distress.”

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.

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