Verona Pharma, a respiratory disease-focused drugmaker, said on Wednesday that the first patients have been dosed in a Phase 2b clinical trial testing RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Verona Pharma expects to report top-line data from this trial in the second half of 2018.
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory, as well as bronchodilator properties, and is currently in development for the treatment of COPD and cystic fibrosis.
The four-week, dose-ranging trial is planned to enroll approximately 400 patients with COPD to investigate the efficacy, safety, and dose-response of nebulized RPL554 as a maintenance treatment for the disease. The primary endpoint of this double-blind, placebo-controlled, parallel group study is improvement in lung function with RPL554 compared to placebo, as measured by FEV1, a standard measure of exhaled breath volume used to evaluate respiratory function.
The trial is being performed at a number of sites across Europe and is part of Verona Pharma’s global strategic services agreement with QuintilesIMS to provide core clinical trial services for RPL554 clinical development programs, as well as provide additional insights to inform development and commercial strategy.
Jan-Anders Karlsson, PhD, CEO of Verona Pharma said that dosing first patients in this larger four-week Phase 2b trial is an important step forward in the evaluation of nebulized RPL554 as a novel therapy for COPD patients with significant unmet medical needs. He added that the clinical data generated to date and the mechanism of action of RPL554 makes it a promising first-in-class treatment option. He concluded: “We look forward to working with patients and healthcare providers across the trial sites to gather meaningful data and insights, and expect to report top-line results from this study in the second half of 2018.”
RPL554 has also shown anti-inflammatory effects and has been well tolerated in clinical trials.