Verona Pharma has initiated phase III trials to evaluate the safety and efficacy of nebulised ensifentrine in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
The ENHANCE clinical trial programme will test the treatment across two trials as either a monotherapy or as an add-on treatment to a single bronchodilator, compared to placebo.
Each study will aim to enrol approximately 800 moderate-to-severe symptomatic COPD patients at sites primarily in the US and EU.
In both of the studies, the primary endpoint will be the improvement in lung function – as measured by forced expiratory volume in one second (FEV1) over 12 hours with ensifentrine after 12 weeks of treatment. Key secondary endpoints will include improvement in COPD symptoms and health-related quality of life.
“We are excited to start our pivotal ENHANCE Phase 3 studies. If successful, the data will support the submission of a New Drug Application in the US. for nebulised ensifentrine for the maintenance treatment of COPD,” said David Zaccardelli, president and chief executive officer of Verona Pharma.
“This is an important milestone for Verona Pharma and we look forward to addressing the urgent need for a novel therapy for the treatment of COPD,” he added.
Ensifentrine is a potentially first-in-class treatment that combines bronchodilator and anti-inflammatory activities into one compound. In prior clinical studies in COPD, the treatment demonstrated clinically meaningful improvements in lung function, symptoms and quality of life as both a monotherapy or added onto a maintenance bronchodilator.