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Trevi Therapeutics Reports Statistically Significant Result on Interim Analysis from the Ph2 CANAL Trial of Nalbuphine ER in the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis

Interim analysis showed primary efficacy endpoint of cough reduction was highly statistically significant (p<0.0001) for Haduvio (nalbuphine ER) Enrollment to be stopped due to strength of the interim data with plans to accelerate development

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Trevi Therapeutics, Inc. (Nasdaq: TRVI) 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.

Trevi Therapeutics 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.”

CANAL Interim Primary Efficacy Endpoint Analysis: (as of January 28, 2022)

N=26, Full Analysis Set Daytime cough frequency at end of treatment period vs. study baseline p-value
Nalbuphine ER BID -77.3% p<0.0001
Placebo BID -25.7%
Placebo-adjusted change -51.6%

Full Analysis Set includes subjects completing at least 1 treatment period.

Supplemental Efficacy Analyses: (as of January 28, 2022)

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.

Arithmetic mean change in daytime cough frequency

Full Analysis Set Completers
vs. Study Baseline vs. Treatment Period Baseline vs. Study Baseline vs. Treatment Period Baseline
All cough counts
Number of subjects, N 26 26 18 18
Mean baseline coughs/hr 31 31 31 31
Nalbuphine ER -67.7% -65.9% -67.0% -65.0%
Placebo -15.9% +12.2% -11.9% +25.6%
Placebo adjusted change -51.8% -78.1% -55.1% -90.6%
Coughs/hr ≥20.5 (50% ITT)
Number of subjects, N 13 13 9 9
Mean baseline coughs/hr 50 50 50 50
Nalbuphine ER -71.7% -70.5% -71.8% -70.5%
Placebo -23.7% -0.7% -25.1% +5.5%
Placebo adjusted change -48.0% -69.9% -46.7% -76.1%

Full Analysis Set includes subjects completing at least 1 treatment period. Completers include subjects completing both treatment periods.

Safety and Tolerability 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.

Next Steps:

Based on the positive interim analysis for the Ph2 CANAL trial, Trevi Therapeutics 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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