Therapy shows a quality of life boost and significant improvement in lung function.
Verona Pharma has announced positive results from its phase 3 ENHANCE-1 trial. The study is evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Ensifentrine is a first-in-class, selective dual inhibitor, combining bronchodilator and non-steroidal anti-inflammatory activities in a single compound.
The research has successfully met its primary and key secondary endpoints showing significant improvements in symptoms, lung function, and quality of life. Meanwhile, ensifentrine significantly reduced the rate and risk of COPD exacerbations and was well tolerated over both 24 and 48-week periods.
Approximately 66% of subjects received background COPD therapy – either a long-acting muscarinic antagonist or a long-acting beta-agonist. Additionally, approximately 21% of all subjects received inhaled corticosteroids.
Patients demonstrated improvements in all subgroups, including gender, age, smoking status, COPD severity, background medication, chronic bronchitis, and geographic region. Improvements in symptoms also appeared early and were sustained with statistical significance versus the placebo.
Furthermore, data from ENHANCE-1 and ENHANCE-2 demonstrated a 40% reduction in the rate of moderate-to-severe COPD exacerbations over 24 weeks compared to those receiving the placebo.
David Zaccardelli, Verona Pharma’s president and chief executive officer, explained: “We are very pleased by the successful outcome of our phase 3 ENHANCE-1 study, bringing us another step closer to providing a much-needed novel therapy for COPD patients.
“The totality of the ENHANCE data including improvements in lung function, symptoms, quality of life measures and reduction in exacerbations, coupled with the consistent, favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD.”
Antonio Anzueto, Professor of Medicine and Section, chief of pulmonary at South Texas Veterans Healthcare System, reflected: “The exciting results demonstrate ensifentrine’s potential to become a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD. The 36% reduction in the rate of exacerbations observed over 24 weeks in symptomatic patients is impressive.
He concluded: “Combined with the significant improvements in lung function, symptom and quality of life measures, as well as the favourable safety profile, these data confirm ensifentrine’s potential to change the treatment paradigm for COPD patients.”
Verona Pharma plans to release additional information from the ENHANCE trials at upcoming scientific conferences.