Business
Trevi Therapeutics Announces Fourth Quarter and Year End 2020 Financial Results and Business Updates
Expects to Complete Enrollment and Report Top-Line Data of the Phase 2b/3 PRISM Trial in Second Half of 2021 Cash Position Expected to Fund Operations into
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"Expects to Complete Enrollment and Report Top-Line Data of the Phase 2b/3 PRISM Trial in Second Half of 2021 Cash Position Expected to Fund Operations into the Second Quarter of 2022 NEW HAVEN, Conn., March 25, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter and year ended December 31, 2020, as well as business highlights. “We made significant progress in the PRISM trial this year, despite the impact of COVID-19 which slowed recruitment activities worldwide through the latter part of 2020 and early 2021. Recruiting for this trial has accelerated this month and we expect to complete enrollment in the third quarter of this year and report top-line results in the fourth quarter of 2021,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “Throughout this past year, we have added to our key talent as we progress through the clinical development of Haduvio in two important indications and prepare for the next phase of development.” Key Business Updates Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis (PN): To date, the Company has enrolled approximately 240 of the 360 planned total subjects in the trial and reaffirms expectations that enrollment will be completed in the third quarter of 2021 and top-line data will be reported in the fourth quarter of 2021. Phase 2 CANAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): This trial is currently being conducted in the United Kingdom, which resumed its shelter in place directive due to COVID-19 in early December 2020 through the end of March 2021. The restrictions paused enrollment for this at-risk patient group during the related time period. We expect to resume recruiting subjects for the trial in the second quarter of 2021. Trevi is also seeking regulatory and ethics board approvals to add study sites in Germany. Fourth Quarter 2020 Financial Highlights Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2020 were $6.6 million compared to $4.8 million in the same period in 2019. The increase was primarily due to increased activity...