Verona Pharma presents expanded analysis of ensifentrine clinical data
Verona Pharma presented clinically relevant findings from its chronic obstructive pulmonary disease clinical trial program with lead product candidate, ensifentrine, at the American Thoracic Society International Conference. Positive results from the 4-week, 400-patient Phase 2b study were initially reported in March 2018. The company said, "The expanded analysis is supportive of the differentiated, dual mechanism of action of ensifentrine, as both a bronchodilator and an anti-inflammatory agent in a single compound. It provides further evidence of the potential for ensifentrine to provide significant symptom benefits to patients." Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown in several previous clinical studies to act both as a bronchodilator and an anti-inflammatory agent in a single compound. It is currently being evaluated in a further Phase 2b clinical trial as an add-on to standard therapy for the maintenance treatment of COPD, with data anticipated around year-end and expected to inform dose selection for Phase 3 trials. Verona Pharma expects to hold an end-of-Phase 2 meeting with the FDA in the first half of 2020 and plans to enter Phase 3 trials in 2020. In addition to advancing the nebulized formulation, Verona Pharma has also developed dry powder inhaler and pressurized metered dose inhaler formulations of ensifentrine. In an ongoing Phase 2 clinical trial, the DPI formulation demonstrated dose-dependent, significant bronchodilation following a single dose, and is currently being evaluated over one week of twice-daily treatment, with top-line data expected in the third quarter this year. The pMDI formulation is planned to enter clinical evaluation in a Phase 2 study in COPD patients later this quarter.