Verona Pharma has reported positive top-line data from a Phase IIb dose-ranging study assessing the efficacy of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD).
The study evaluated nebulised ensifentrine in four dose levels or placebo as an add-on treatment to tiotropium (Spiriva Respimat), a long-acting anti-muscarinic (LAMA) bronchodilator, in patients with moderate to severe COPD.
The subjects, treated with ensifentrine added on to inhaled tiotropium, met the study’s primary endpoint of improved lung function. The study will also help to determine the drug doses in Phase III studies, which are scheduled to begin in the third quarter of 2020.
Principal investigator of the study Gary Ferguson said: “The strong effect on both bronchodilation and quality of life as an add-on to tiotropium is impressive and consistent with prior studies with ensifentrine.”
Overall, the study ran for four weeks and included 416 patients.
Verona Pharma CEO Jan-Anders Karlsson said: “We are delighted with these results in symptomatic COPD patients already on steady-state maintenance treatment with a long-acting LAMA bronchodilator.
“These data bring clarity to planning the design, including dose selection, endpoints and background therapy, of our Phase III programme.
“We look forward to discussing these new and compelling data, together with the positive results from our previous clinical studies, in an end of Phase II meeting with the FDA planned for 2Q 2020.”
COPD is a life-threatening respiratory disease that damages the lungs and airways, leading to breathlessness. According to the World Health Organization, COPD is set to become the third leading cause of death worldwide by 2030.