Verona Pharma said that the Phase 3 ENHANCE-2 trial of nebulized ensifentrine for treatment of COPD met its primary endpoint, with an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 94 ml at week 12. In addition, a number of secondary endpoints were met, and for patients who got ensifentrine, the rate of exacerbations was reduced by 42% over 24 weeks compared to patients who got an inhaled placebo.
The company announced the initiation of the Phase 3 ENHANCE program in September 2020. The ENHANCE-2 trial enrolled 789 COPD patients who received 3 mg of nebulized ensifentrine twice daily, either alone or as an add-on to either a LAMA or a LABA, or placebo. According to Verona, a little over half of the subjects got either a LAMA or LABA during the study and 15% also received ICS.
Verona President and CEO David Zaccardelli commented, “We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible. These data, along with results from our ongoing Phase 3 trial, ENHANCE-1, which is on track to be reported around the end of 2022, if similarly positive, are expected to support the submission of a New Drug Application to the US Food and Drug Administration in the first half of 2023. We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD.”
The company’s pipeline also includes MDI and DPI formulations of ensifentrine for COPD.
Read the Verona Pharma press release.
