Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe COPD exacerbations over 24 weeks and a 38% smaller risk of exacerbations compared to those getting a placebo.
The ENHANCE clinical program was initiated in September 2020. Verona reported that the ENHANCE-2 trial had met its primary endpoint in August 2022.
Verona President and CEO David Zaccardelli commented, “We are very pleased by the successful outcome of our Phase 3 ENHANCE-1 study, bringing us another step closer to providing a much needed novel therapy for COPD patients. The totality of the ENHANCE data including improvements in lung function, symptoms, quality of life measures and reduction in exacerbations, coupled with the consistent, favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. We plan to submit a New Drug Application to the US Food and Drug Administration in the first half of 2023. We would like to thank all the patients and investigators for their participation in the ENHANCE program and we look forward to keeping you updated on our progress.”
Read the Verona Pharma press release.
