Verona Pharma said that a Phase 2b dose-ranging study of its RPL554 nebulized ensifentrine as an add on to tiotropium for the treatment of COPD met its primary endpoint at all doses tested. The company had announced initiation of the study in May 2019.
The 4 week study, which enrolled 416 moderate-to-severe COPD patients, compared 0.375 mg, 0.75 mg, 1.5 mg, and 3.0 mg doses of nebulized ensifentrine as an add on treatment to tiotropium to placebo as an add-on treatment. All of the doses produced clinically meaningful and statistically significant improvement in FEV1 at week 4. The improvement was dose dependent, with improvement ranging from 78 mL for the lowest dose to 124 ml for the highest dose. The study also demonstrated statistically significant improvements in quality of life for the two highest doses.
Verona Pharma CEO Jan-Anders Karlsson commented, “We are delighted with these results in symptomatic COPD patients already on steady-state maintenance treatment with a long-acting LAMA bronchodilator. These data bring clarity to planning the design, including dose selection, endpoints and background therapy, of our Phase 3 program. We look forward to discussing these new and compelling data, together with the positive results from our previous clinical studies, in an End-of-Phase 2 meeting with the FDA planned for 2Q 2020. We are committed to demonstrating ensifentrine’s potential to produce sustained bronchodilation and anti-inflammatory effects in symptomatic COPD patients in Phase 3 trials, which we expect to start in 3Q 2020.”
Verona is also developing ensifentrine as a DPI and as an MDI. The company reported positive results from a Phase 2 study of the ensifetrine DPI in March 2019 and initiated a Phase 2 trial of the MDI formulation in June 2019.
Read the Verona Pharma press release.
