Verona Pharma has announced the initiation of a Phase 2b trial of its ensifentrine MDI for the treatment of COPD in the UK, with results expected in the first half of 2021. In March 2020, Verona announced positive results from a Phase 2a trial of the MDI and noted that the second part of the trial would be delayed due to the COVID-19 pandemic.
The Phase 2b trial will compare twice daily doses of 300 µg, 1000 µg, or 3000 µg ensifentrine to placebo over 4 7-day treatment periods, with each patient getting each dose and placebo over the course of the trial. The primary endpoint will be improvement in peak FEV1.
The company also noted its plans to initiate a clinical trial of the ensifentrine MDI in hospitalized patients with COVID-19. That trial will take place at the University of Alabama Birmingham.
Verona Pharma President and CEO David Zaccardelli commented, “We are pleased to start the multiple dose part of this pMDI study and expect the results in the first half of 2021. Data from the single dose part of this pMDI study are very encouraging and consistent with data from Phase 2 clinical trials with our nebulized and dry powder inhaler (“DPI”) formulations of ensifentrine.”
Read the Verona Pharma press release.
