Verona Pharma has commenced a Phase IIb clinical trial to assess nebulised ensifentrine (RPL554) in combination with a long-acting bronchodilator to treat moderate to severe chronic obstructive pulmonary disease (COPD).
Ensifentrine is a dual inhibitor of the phosphodiesterase 3 and 4 enzymes. It demonstrated the capability to act as a bronchodilator as well as an anti-inflammatory agent.
The randomised, double-blind, dose-ranging Phase IIb trial is designed to investigate the safety and efficacy of nebulised ensifentrine when added on to inhaled tiotropium over four weeks in around 400 patients at nearly 50 sites in the US.
The primary endpoint of the study is an improvement in lung function, measured by peak forced expiratory volume in one second (FEV1), after four weeks of therapy. FEV1 will be measured from zero to three hours post-dosing.
In addition, the trial will track other endpoints, including measurements of respiratory symptoms and quality of life using various patient-reported outcome tools.
Data from the study is set to be available by year-end and expected to inform of dose selection, patient population, background therapy and clinical endpoints for Phase III development, which is being planned for next year.
Verona Pharma CEO Jan-Anders Karlsson said: “In addition to further evaluating the potential of nebulised ensifentrine as a first-in-class therapy in symptomatic COPD patients already receiving a long-acting bronchodilator, this study is an important step towards optimising the clinical profile of ensifentrine for the planned end-of-Phase II meeting with the FDA in the first half of 2020.
“The study is also expected to further inform the Phase III clinical development programme for ensifentrine in terms of dose selection, patient population, background therapy and clinical endpoints.”
Previous Phase II trials showed significant and clinically meaningful improvements in lung function and COPD symptoms in moderate to severe COPD patients treated with ensifentrine.
The company has also formulated the drug as a dry powder inhaler (DPI) and a pressurised metered dose inhaler (pMDI).