Independent Data Monitoring Committee Recommends Continuation of PRISM Trial with Expansion to 360 Subjects per the Adaptive Design
Enrollment Expected to be Complete by Third Quarter 2021
Introducing HADUVIO™ as Proposed
Based on the SSRE analysis the independent Data Monitoring Committee (DMC) recommended that the PRISM trial should continue and that the trial size should increase from an initial enrollment target of 240 to 360 subjects which maintains the statistical power for the primary endpoint. The DMC’s 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 DMC’s recommendation, the Company plans to increase the size of the trial to 360 subjects.
“Severe pruritus in prurigo nodularis is a very serious and difficult-to-treat condition. We are pleased with the re-estimation results midway through the trial which inform the sample size and further reinforces our view that Haduvio may be an effective treatment option for patients with PN,” said
PRISM Phase 2b/3 Trial Design
The PRISM trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Haduvio for severe pruritus in patients with prurigo nodularis. In this trial, subjects are randomized equally across two treatment groups (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 patients 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, after which all participants rollover to an open-label extension.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in
Statements contained in this press release 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 our clinical trials, business and operations; the expected timing of enrollment, and for reporting top-line data from, Trevi’s Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi’s business plans and objectives, including future plans or expectations for Trevi’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 Trevi’s 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 Trevi’s clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi’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