Item 8.01 Other Events

On February 1, 2022, Trevi Therapeutics, Inc. (the “Company”) announced that it has completed enrollment in its Phase 2b/3 PRISM trial for pruritus associated with prurigo nodularis (“PN”) and expects to report top-line data in the second quarter of 2022.

The PRISM trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Haduvio™ (nalbuphine ER) for severe pruritus in patients with PN. In the trial, subjects are randomized equally across two treatment groups (oral Haduvio 162 mg or placebo, twice daily including an initial 2-week blinded titration period). The primary endpoint of the trial is the proportion of subjects achieving a greater than or equal to 4-point improvement in the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14 compared to baseline. The planned enrollment for the trial was approximately 360 subjects.

The Company previously announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation to nalbuphine ER for the proposed indication of reduction of moderate to severe pruritus in patients with PN. Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.  

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 reporting top-line data from the Company’s Phase 2b/3 PRISM trial of Haduvio in patients with PN; 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 the timing of the planned interim analysis for the CANAL trial and of top-line data from both the PRISM and CANAL trials; 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.