Item 8.01 Other Events.
On July 13, 2020, Trevi Therapeutics, Inc. (the Company) announced the completion of the pre-specified
sample size re-estimation (the SSRE) analysis for its ongoing PRISM Phase 2b/3 trial of Haduvio (nalbuphine ER) for severe pruritus
in patients with prurigo nodularis.
Based on the SSRE analysis, the independent Data Monitoring Committee (the DMC) recommended that the
trial size should be increased from an initial enrollment target of 240 to 360 subjects, which maintains the statistical power for the primary endpoint of the trial. The DMCs recommendation was based on a
pre-specified interim conditional power assessment conducted after approximately 45% of the initial targeted number of patients were evaluable for the primary endpoint of the trial. Based on the DMCs
recommendation, the Company plans to increase the size of the trial to 360 subjects.
The Company has increased the number of active sites in the PRISM
trial to more than 60 sites globally, and approximately 140 subjects have enrolled in the study. Based on the increased size of the trial and considering COVID-19 related restrictions, the Company expects to
complete enrollment in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.
Company intends to propose Haduvio as the trade name for the nalbuphine ER investigational product and will therefore use that name in its materials going forward. Haduvio is an investigational drug product and its safety and efficacy have not been
fully evaluated by any regulatory authority.
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 impact of the COVID-19 pandemic on the Companys clinical trials, business and operations; the
expected timing of enrollment, and for reporting top-line data from, the Companys Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; the Companys business plans and objectives,
including future plans or expectations for the Companys 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 Companys product candidate development activities and ongoing and planned clinical trials; uncertainties
regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on the Companys clinical operations and actions taken in
response to the pandemic; uncertainties regarding the Companys 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 inherent in estimating future expenses, capital requirements and other financial results; as well as other risks and uncertainties set forth in the quarterly
report on Form 10-Q for the quarter ended March 31, 2020 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.