Verona Pharma plc a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that the first patients have been dosed in a Phase 2b clinical trial evaluating 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.
“Dosing our 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,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “The clinical data generated to date and the mechanism of action of RPL554 makes it a promising first-in-class treatment option. 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.”
In previous clinical trials in patients with COPD, RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo and has shown clinically meaningful and statistically significant improvements in lung function when added to two commonly used bronchodilators as compared to either bronchodilator administered as a single agent. RPL554 has also shown anti-inflammatory effects and has been well tolerated in clinical trials.
About Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease for which there is no cure. The condition damages the airways and the lungs, leading to cough, mucus secretion and shortness of breath, impacting a person's ability to perform daily activities. According to the World Health Organization, COPD is the third leading cause of death globally, with 210 million people worldwide suffering from the disease. Current therapies to treat COPD are aimed at reducing and controlling symptoms. Despite the wide availability of these therapies, many COPD patients continue to suffer acute periods of worsening symptoms known as exacerbations. In the U.S. alone, these exacerbations are associated with approximately 1.5 million emergency department visits, 687,000 hospitalizations, and 129,000 deaths per year. The total annual medical costs related to COPD in the U.S. were estimated to be $32 billion in 2010, and are projected to rise to $49 billion in 2020.
