Chronic obstructive pulmonary disease phase 3 study shows statistically significant improvements in lung function
Verona Pharma has announced its top-line phase 3 ENHANCE-2 trial results evaluating nebulised ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
The trial has successfully met its primary endpoint, as well as secondary endpoints, demonstrating improvements in lung function and a significantly reduced risk of COPD exacerbations.
Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and anti-inflammatory activities in a single compound.
The study, which involved over 700 participants, showed statistically significant and clinically meaningful improvements with ensifentrine. This included gender, age, smoking status, COPD severity, background medication, chronic bronchitis and FEV1 reversibility subgroups.
Subjects receiving ensifentrine also demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo. Furthermore, treatment with the therapy significantly decreased the risk of a moderate or severe exacerbation as measured by time to first exacerbation when compared with placebo.
Antonio Anzueto, chief of pulmonary at South Texas Veterans Healthcare System, explained: “Ensifentrine has demonstrated clear improvements in lung function in addition to favourable safety results. I am extremely excited by the clinically meaningful 42% reduction in the rate of exacerbations observed over 24 weeks in these symptomatic patients, many receiving background therapy.”
“Based on these meaningful results, I believe ensifentrine, if approved, will be an important new class of bronchodilator and non-steroidal anti-inflammatory therapy for COPD patients providing a much needed alternative to existing treatments,” he added.
David Zaccardelli, Verona’s chief executive officer, concluded: “We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible. We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD.”
Verona plans to release additional information from ENHANCE-2 at upcoming scientific conferences.