Business
Trevi Therapeutics Announces First Quarter 2020 Financial Results and Corporate Update
Sample Size Re-Estimation Analysis for PRISM Trial Expected in Mid-2020 New Patient Screening Re-Starting at PRISM Sites in the US and Europe Cash Position of
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Sample Size Re-Estimation Analysis for PRISM Trial Expected in Mid-2020\n New Patient Screening Re-Starting at PRISM Sites in the US and Europe Cash Position of $52.6 Million Expected to Fund Operations into the Fourth Quarter of 2021 NEW HAVEN, Conn., May 07, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended March 31, 2020, as well as recent business highlights. “We are pleased to announce that we have completed enrollment of the patients necessary to conduct the sample size re-estimation analysis in our PRISM trial and expect to announce the results of this analysis in mid-2020,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “With the ongoing COVID-19 pandemic, we have experienced some disruption to new patient screening and enrollment in the PRISM trial, however, our clinical sites are beginning to screen new patients and we expect most of our sites will begin to screen and enroll new patients in May and June. Importantly, we have not had any patient discontinuations in the blinded portion of the trial related to COVID-19 and substantially all patients on treatment were able to complete their required visits. We plan to provide guidance on the expected timing of top-line results from the PRISM trial when we announce the results from the sample size re-estimation analysis in mid-2020.” Key Product Pipeline Updates Phase 2b/3 PRISM trial of nalbuphine ER for severe pruritus in patients with prurigo nodularis: The pace of enrollment in the PRISM trial has been impacted by the COVID-19 pandemic with new patient screening and most patient enrollment temporarily halted. Patient screening restrictions have been lifted in the United States and are in the process of being lifted in Europe. We expect many of our sites will restart patient screening and enrollment throughout May and June 2020. The protocol for the PRISM trial provides for a sample size re-estimation (SSRE) analysis once approximately 50% of the patients in the trial are evaluable for the primary endpoint. In light of the pandemic-related delays, we have decided to conduct the SSRE analysis once approximately 45% of the pat...