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New Information on Chronic Cough in Idiopathic Pulmonary Fibrosis

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Trevi Therapeutics, Inc. today announced positive interim analysis results of the Phase 2 Cough And NALbuphine (CANAL) trial of its investigational therapy Haduvio™ (nalbuphine ER) in idiopathic pulmonary fibrosis patients (IPF) suffering from chronic cough, establishing proof of concept. Further patient recruitment in the trial will stop based on the strength and consistency of the data.

The Company conducted a statistical analysis to assess the probability of success of CANAL based on the interim data. The results of that analysis revealed that there was a 100% chance of success on existing data and the Company has moved to end screening and conclude enrollment into CANAL. The interim analysis (N=26) was statistically significant on the primary efficacy endpoint, demonstrating a 52% placebo-adjusted reduction in the geometric mean percent change in daytime cough events (p<0.0001, conditional power 100%) for Haduvio. The interim analysis was conducted by an independent statistical team according to the pre-specified endpoint in the protocol.

“We are excited about the clinically and highly statistically significant results of Haduvio in the CANAL trial and the potential to treat chronic cough in IPF patients,” said Dr. Bill Forbes, Chief Development Officer at Trevi Therapeutics. “Chronic cough in patients with IPF is a serious complication of a terminal disease with no approved therapies. 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 for chronic cough in patients with IPF.”

“These are extremely encouraging results that show the potential of nalbuphine ER to significantly improve the debilitating chronic cough which often severely impacts quality-of-life in many patients with IPF,” said Dr. Toby Maher, MD, Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California. “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. Chronic cough is a frequent symptom affecting IPF patients which contributes to emotional, physical, and psychological distress.”

The supplemental efficacy analyses from the CANAL interim data support the strong results seen in the primary efficacy endpoint. The supplemental analyses showed consistency when analyzed for completers of both treatment periods in the crossover design, against treatment period baseline, and baseline cough counts. Secondary endpoints of patient reported outcome measure changes were consistent with the improvement in daytime cough frequency results.

Nalbuphine ER has been well-tolerated in the CANAL trial and has been studied in more than 1,000 subjects across indications. The safety profile remains consistent with prior studies with no new safety signals. One SAE has been reported in the CANAL trial to date and was not considered to be treatment related.

Based on the positive interim analysis for the Ph2 CANAL trial, Trevi has determined to stop further recruitment into the CANAL trial and plans to initiate discussions with Health Authorities regarding the next study. The Company plans to report data from the full CANAL trial early in the third quarter 2022 and will include the patients enrolled in January and February of this year, which we expect to total approximately 40 subjects.

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

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