Verona Pharma has announced that a Phase 2 trial of 5 dosage strengths of an MDI formulation of ensifentrine for the treatment of moderate to severe COPD demonstrated that all but the lowest dose of ensifentrine produced statistically significant and clinically meaningful improvement in lung function compared to placebo. The 40 COPD patients enrolled in the trial each received a single dose of 100 mcg, 300 mcg, 1000 mcg, 3000 mcg, or 6000 mcg ensifentrine or placebo.
Based on the results of the first part of the trial, the company plans to go ahead with the second portion of the trial in which patients would receive ensifentrine twice a day for 7 days; however, due to the COVID-19 pandemic, initiation of that portion of the trial will be delayed until further notice. The company said that its end of Phase 2 meeting with the FDA is currently scheduled for the second quarter of this year.
Earlier this year, Verona announced positive results from a Phase 2b trial of nebulized ensifentrine as add-on to tiotropium for the treatment of COPD. Phase 3 studies of the nebulized formulation are expected for later in 2020. The company also announced positive results from a Phase 2 study of a DPI formulation of ensifentrine for COPD in August 2019.
Verona Pharma President and CEO David Zaccardelli commented, “Across all three inhaled formulations, ensifentrine has demonstrated statistically significant and clinically meaningful lung function improvements and duration of action, supporting twice-daily dosing and a safety profile similar to placebo. The results from the single dose part of this pMDI study are very encouraging and essentially consistent with data from Phase 2 clinical trials with nebulized and DPI formulations of ensifentrine.”
Read the Verona Pharma press release.
