Phase 3 Study of Ensifentrine Meets Primary, Secondary Endpoints
The medication showed significant efficacy for treating patients with moderate to severe COPD exacerbations.
The Phase 3 ENHANCE-1 clinical trial evaluating nebulized ensifentrine as a maintenance therapy for chronic obstructive pulmonary disease (COPD) has met its primary and key secondary endpoints, according to a news release from Verona Pharma.1
In addition to these milestones, investigators found that ensifentrine reduced both the rate and risk of exacerbations from COPD. It is a first-in-class, selective dual inhibitor of phosphodiesterase 3 and 4 enzymes.
ENHANCE-1 (NCT04535986) included 763 patients with moderate to severe symptomatic COPD at sites across North America and Europe. Participants were randomly assigned to receive either a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 or 48 weeks. The primary endpoint was improved lung function; key secondary endpoints included improved quality of life and symptom improvements.
Investigators found that the placebo corrected change from baseline in forced expiratory volume (FEV1) area under the curve (AUC) 0 to 12 hours after dosing was 87 mL (P <.0001) at week 12. Those in the ensifentrine group also experienced consistent improvements across all subgroup evaluations, including gender, age, smoking status, and COPD severity, among others.
Symptom improvement was early and sustained in comparison to placebo at weeks 6, 12, and 24, with similar results seen in quality-of-life measures. Additionally, investigators noted a 36% reduction in moderate to severe COPD exacerbations ensifentrine group. The agent was also well-tolerated by participants, with few events occurring during the study period.
In a release announcing the results, Antonio Anzueto, MD, Professor of Medicine and Section, Chief of Pulmonary at South Texas Veterans Healthcare System, commented on the results, saying, “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 patients.”
Reference
1. Verona Pharma announces ensifentrine meets primary and key secondary endpoints in phase 3 ENHANCE-1 trial for COPD. News Release. Verona Pharma. January 5, 2023. Accessed January 19, 2023. https://www.veronapharma.com/media/verona-pharma-announces-ensifentrine-meets-primary-and-key
