Benzinga | Oct 21, 2020 08:02AM EDT

Trevi Therapeutics Announces Resumption Of Patient Screening In Phase 2 Clinical Trial Of Haduvio For Chronic Cough In Patients With IPF

Restart of Phase 2 Clinical Trial of Haduvio for Chronic Cough in Patients with IPF



Phase 2b/3 PRISM Trial of Haduvio for Severe Pruritus in Patients with Prurigo Nodularis Reaches 50% Enrollment Milestone

NEW HAVEN, Conn., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio(tm) (nalbuphine ER) to treat serious neurologically mediated conditions, today, announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population for COVID-19. In addition, the Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis, randomized its 180th subject, officially reaching 50% enrollment.

Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in patients with IPF that is being conducted in the United Kingdom (UK). The study is designed to enroll approximately 60 subjects with a goal to have 44 study completers. The primary endpoint for the study is the mean percent change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints.

Professor Toby Maher, based at the Royal Brompton Hospital and the lead investigator for this Phase 2 trial, said, "I am pleased to see Trevi's trial for chronic cough in IPF patients restart screening after pausing due to the COVID-19 pandemic. IPF is a debilitating disease, with chronic cough being a significant contributor to a patient's reduced quality of life. Nalbuphine ER is of particular interest for the clinical treatment of chronic cough due to the potential of its mixed agonist/antagonist mechanism of action."

"The Company has worked with Dr. Maher to amend the protocol to require fewer in-person visits by the subjects as well as fewer procedures," said Dr. Thomas Sciascia, Trevi's Chief Medical Officer. "We believe this better protects the overall safety of these patients during the time of the pandemic."

The amended protocol was recently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and patient screening has restarted at certain sites in the UK. Additionally, Trevi is analyzing the possible addition of study sites in Germany to potentially accelerate enrollment and mitigate the COVID-related risks inherent to recruitment from a single-country.

Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis

During October, the PRISM trial randomized its 180th subject into the study, reaching 50% enrollment of the expanded trial size following the sample size re-estimation completed in July. We expect to complete enrollment in the PRISM trial in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.

"We are pleased with the continued progress of our clinical development programs in these two severe conditions," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We have seen continued momentum in the enrollment in the PN trial and look forward to helping the remaining clinical sites for cough in IPF get restarted."