Business
Trevi Therapeutics Announces Third Quarter 2020 Financial Results and Business Update
PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis Exceeds Halfway Enrollment Milestone Phase 2 Chronic Cough Trial in Patients
About this update from Trevi Therapeutics, Inc.
[{"type":"text","content":"PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis \n Exceeds Halfway Enrollment Milestone Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions Cash Position Expected to Fund Operations into the First Half of 2022 NEW HAVEN, Conn., Nov. 11, 2020 (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 ended September 30, 2020, as well as business updates. “We are pleased with the continued progress of our clinical development programs,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “We recently announced significant developments in both of our ongoing clinical trials by surpassing halfway enrollment in our PRISM trial and enrolling the first new subject in our chronic cough trial in IPF since the study resumed after pausing due to COVID restrictions. We are focused on completing enrollment in both trials and preparing for the next steps in the development of Haduvio.” Key Business Updates Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company has enrolled approximately 190 subjects in the trial and reaffirms its guidance that it expects to complete enrollment in the third quarter of 2021 and to report top-line data in the fourth quarter of 2021. Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Company resumed screening and enrolling patients in the trial following the pause in the trial due to COVID-19. The Company amended the study protocol to require fewer in-person visits by subjects as well as fewer procedures in order to facilitate the completion of the trial in an at-risk patient population for COVID-19. Additionally, the Company is assessing additional study sites in Germany which could potentially accelerate enrollment and reduce the risks inherent with single-country recruitment during the COVID-19 pandemic. Third Quarter 2020 Financial Highlights Cash position: As of September 30, 2020, the Company had total cash and cash equivalents of $53.3 million, compared to $57.3 million as of December 31, 2019. Dur...