Business
Trevi Therapeutics Announces Third Quarter 2019 Financial Results and Recent Business Developments
Advancement of Nalbuphine ER in Clinical Development for Three Indications Cash Position of $63.5 Million Expected to Fund Operations Through At Least Q1 2021
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Advancement of Nalbuphine ER in Clinical Development for Three Indications \n Cash Position of $63.5 Million Expected to Fund Operations Through At Least Q1 2021 NEW HAVEN, Conn., Nov. 14, 2019 (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 September 30, 2019, as well as recent business highlights. “We have made substantial progress this year advancing the development of nalbuphine ER across all of our clinical indications. We continued to progress our lead development program in prurigo nodularis during the third quarter with further enrollment and continued site initiations in Europe and the US. We have had 100% of the patients that completed the blinded 14-week dosing continue into the open label extension portion of the study,” 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 have completed dosing of subjects with mild to moderate liver impairment in our Phase 1b study in patients with chronic liver disease. While the pace of enrollment in our PN trial has been slower than originally planned, our team remains focused on completing this trial, as well as those in our other clinical indications, each of which represents a significant unmet medical need.” Product Pipeline Updates Phase 2b/3 PRISM trial: 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 50 centers in the U.S. and Europe. To date, the Company has enrolled approximately 30% of the targeted number of patients in the study. The pace of enrollment has been slower than anticipated primarily due to competition from other clinical trials and slower than planned site start-ups in Europe. As a result, 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 tri...