Verona Pharma has announced that a Phase 2 trial of its RPL554 ensifentrine DPI for the treatment of COPD met all primary and secondary endpoints related to improvement in lung function. The company had previously announced positive preliminary results from the study. Phase 2 studies of nebulized ensifentrine and an ensifentrine MDI for the treatment of COPD were initiated earlier this year.
The second part of the study, which enrolled 35 patients with moderate-to-severe COPD, evaluated 4 doses of ensifentrine (150 µg, 500 µg, 1500 µg, and 3000 µg) and placebo over one week. According to the company, the study demonstrated highly statistically significant improvements over baseline in peak FEV1 for all doses ranging from 102 mL for the 150 µg dose to 260 mL for the 3000 µg dose. The study also showed statistically significant improvement in average FEV1 for all doses.
Verona Pharma CEO Jan-Anders Karlsson commented, “These very promising data with the DPI formulation support our view that ensifentrine is an effective bronchodilator in COPD patients, whether administered as a dry powder via a handheld inhaler or as a suspension via a nebulizer. Our proof-of-concept dry powder formulation can be adapted to different DPI devices used in the market. Millions of patients prefer to use a handheld device, and these data significantly expand ensifentrine’s commercial potential. We plan to complete further development and commercialization of the DPI formulation with a partner and these clinical data strongly support this opportunity.”
Read the Verona Pharma press release.
