Item 8.01 Other Events

On January 5, 2022, Trevi Therapeutics, Inc. (the “Company”) announced that it expects to perform an interim statistical update in the first quarter of 2022 for its ongoing Phase 2 CANAL trial of Haduvio™ (nalbuphine ER) in patients suffering from chronic cough due to idiopathic pulmonary fibrosis (“IPF”). The Company intends to conduct the interim statistical update for the Phase 2 CANAL trial based on a conditional power assessment. The Phase 2 CANAL trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study. An independent statistician will review the pre-planned analysis on the primary endpoint of change in daytime cough frequency for oral nalbuphine ER compared to the placebo. The Company plans to use the information from the statistical update to determine whether proof-of-concept can be established prior to the full enrollment of the trial.  The Company expects top-line data from the Phase 2 CANAL trial in the first half of 2022.

The Company also announced that it expects to end enrollment in its Phase 2b/3 PRISM trial for the treatment of pruritus associated with prurigo nodularis (“PN”) by January 31, 2022. The Company continues to expect top-line data from the 14-week blinded portion of the Phase 2b/3 PRISM trial in the first half of 2022.

Forward-Looking Statements

Statements contained in this current report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the expected timing of enrollment and for reporting top-line data from the Company’s Phase 2b/3 PRISM trial of Haduvio in patients with PN and for the interim analysis and top-line data from the Phase 2 CANAL trial of Haduvio for chronic cough in patients with IPF; the Company’s business plans and objectives, including future plans or expectations for the Company’s product candidates; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of the Company’s product candidate development activities and ongoing and planned clinical trials, including with respect to enrollment and the timing of the planned interim analysis and of top-line data; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on the Company’s clinical operations and actions taken in response to the pandemic; uncertainties regarding the Company’s ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties regarding fast track designation and the effect such status could have on the regulatory review or approval process;  uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results; including the Company’s ability to continue as a going concern and its obligations under its loan facility; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2021 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this current report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.