Business
TREVI THERAPEUTICS ANNOUNCES FOURTH QUARTER AND YEAR END 2019 FINANCIAL RESULTS AND CORPORATE UPDATE
Enrollment in PRISM Study Progressing - Sample Size Re-estimation Planned for mid-2020 Expect to Report Top-Line Data in both PN and IPF-Cough Trials in
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Enrollment in PRISM Study Progressing - Sample Size Re-estimation Planned for mid-2020\n Expect to Report Top-Line Data in both PN and IPF-Cough Trials in Second Half of 2020 Cash Position of $57.3 Million Expected to Fund Operations into the Third Quarter of 2021 NEW HAVEN, Conn., March 16, 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 and year ended December 31, 2019, as well as recent business highlights. “We made substantial progress in 2019 advancing the development of nalbuphine ER across our clinical indications and expect 2020 to be an important year for Trevi with clinical data expected in our two lead indications. We continued to progress our lead development program in prurigo nodularis, and expect to achieve 50% enrollment in the PRISM study in the second quarter of 2020 with the sample size re-estimation in mid-2020 and top-line data from this study in the second half of 2020,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “We are also actively enrolling the cough study in idiopathic pulmonary fibrosis patients in the UK and expect to report top-line data in the second half of 2020 as well.” Key Product Pipeline Updates Phase 2b/3 PRISM trial of nalbuphine ER for severe pruritus in patients with prurigo nodularis (PN): The ongoing PRISM trial is a randomized, double-blind, placebo controlled, two-arm treatment study that is designed to evaluate the safety and anti-pruritic efficacy of nalbuphine ER in approximately 240 patients with severe pruritus from PN in approximately 60 centers in the U.S. and Europe. To date, the Company has enrolled approximately 45% of the targeted number of patients in the study. The Company expects to report top-line data from the PRISM trial in the second half of 2020. Additionally, the protocol for the PRISM trial provides for a sample size re-estimation analysis once 50% of the patients in the trial are evaluable for the primary endpoint. Trevi expects to reach 50% patient enrollment during the second quarter of 2020 and that the re-estimation analysis will occur in mid-2020.Phase 2 trial of nalbuphine ER for chronic cough in patients with ...