Verona Pharma plc has announced positive results of its phase 3 ENHANCE-1 trial evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
The ENHANCE-1 trial successfully met its primary and key secondary endpoints demonstrating significant improvements in lung function, symptoms and quality of life measures. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations. Ensifentrine was well tolerated over 24 and 48 weeks.
Ensifentrine is a first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one compound.
‘Exciting results’ for Verona Pharma‘s Ensifentrine
Antonio Anzueto, professor of Medicine and section chief of pulmonary at South Texas Veterans Healthcare System, said: “These exciting results demonstrate ensifentrine’s potential to become a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD.
“The 36% reduction in the rate of exacerbations observed over 24 weeks in symptomatic patients is impressive. Combined with the significant improvements in lung function, symptom and quality of life measures, as well as the favorable safety profile, these data confirm ensifentrine’s potential to change the treatment paradigm for COPD patients.”
David Zaccardelli, Verona Pharma’s president and chief executive officer, said: “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.”
Verona Pharma plans to release additional information from the ENHANCE trials at upcoming scientific conferences.