Verona Pharma has published Phase II trial results for ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
The results, published in Respiratory Research, showed that the study met its primary endpoint demonstrating that ensifentrine produced clinically and statistically significant improvements in lung function at all doses. Also, clinically relevant secondary endpoints were met including significant progressive improvements in COPD symptoms.
The “compelling” data from Verona’s two successful Phase IIb studies in COPD, “one in patients with no background therapy and the second in symptomatic patients already on maintenance therapy, are further evidence of ensifentrine’s promising therapeutic potential.
“We look forward to discussing these results, along with positive data from previous clinical studies, in an End-of-Phase II meeting with the FDA, anticipated for 2Q 2020. We expect this meeting to provide key guidance with respect to the design of our Phase III program.”
In August last year, the company announced that the treatment showed highly statistically significant and clinically meaningful dose-dependent improvement in lung function, with secondary data supporting twice daily dosing and showing that ensifentrine was well tolerated at all dose levels.
It also revealed positive results from the first part of the trial in March, which demonstrated a single dose of ensifentrine produced a statistically significant and clinically meaningful dose-dependent bronchodilator response.
COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organisation estimates that it will become the third leading cause of death worldwide by 2030.