Verona Pharma said that it has initiated a Phase 2b dose-ranging study of RPL554 nebulized ensifentrine for the treatment of COPD, with results expected by the end of 2019. The company, which reported positive results from a Phase 2 study of an ensifetrine DPI in March 2019, said that it also expects to start a Phase 2 trial of an ensifetrine MDI for COPD this quarter and a Phase 3 trial of RPL554 for COPD next year.
The four-week, randomized, double-blind, dose-ranging Phase 2b study is expected to enroll about 400 COPD patients who will receive ensifentrine via nebulizer twice a day in addition to a LAMA over 28 days. The study will evaluate 4 doses of ensifentrine: 0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg. The primary endpoint will be the increase in FEV1 after 4 weeks of treatment.
Verona Pharma CEO Jan-Anders Karlsson commented, “In addition to further evaluating the potential of nebulized ensifentrine as a first-in-class therapy in symptomatic COPD patients already receiving a long-acting bronchodilator, this study is an important step towards optimizing the clinical profile of ensifentrine for the planned End-of-Phase 2 meeting with the FDA in the first half of 2020. The study is also expected to further inform the Phase 3 clinical development program for ensifentrine in terms of dose selection, patient population, background therapy and clinical endpoints.”
Read the Verona Pharma press release.
