Practice-changing results for ensifentrine in COPD

In 2 phase 3 trials, ensifentrine significantly improved lung function, symptoms, and exacerbation rates in patients with GOLD class B COPD. The efficacy results were consistent across subgroups. Furthermore, ensifentrine was well tolerated and did not exceed placebo in terms of adverse event rates. 

“Ensifentrine has anti-inflammatory effects, provides mucociliary clearance, and is a bronchodilator,” said Prof. Antonio Anzueto (University of Texas Health San Antonio, TX, USA). This agent was tested in the phase 3 ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) trials as an inhaled nebulised therapy for patients with GOLD class B COPD [1]. In the ENHANCE-1 trial, 300 patients were randomised to ensifentrine and 100 patients were randomised to placebo. Corresponding participant numbers in the ENHANCE-2 trial were 500 and 300, respectively. In both trials, the primary endpoint was the mean change from baseline forced expiratory volume in 1 second (FEV1) area under the curve (AUC) 0–12 hours at week 12. 

In both trials, the primary endpoint was met. For the ENHANCE-1 trial, the mean change from baseline FEV1 AUC 0-12 hours was +87 ml (P<0.001). The corresponding result for the ENHANCE-2 trial was +94 ml (P<0.001). Prof. Anzueto mentioned that there were also improvements seen with regard to symptoms, quality of life, and the use of rescue medication. Importantly, the exacerbation rate reductions after 24 weeks for patients receiving ensifentrine were 36% and 43% for the ENHANCE-1 and ENHANCE 2 trials, respectively. Finally, the safety profile of ensifentrine was comparable with that of placebo, with serious treatment-emergent adverse event rates of 6–7% for the ensifentrine arms and the placebo arms. 

1. Anzueto A, et al. Effect of ensifentrine, a novel PDE3 and PDE4 inhibitor, on lung function, symptoms, and exacerbations in patients with COPD: the ENHANCE trials. B13,  ATS International Conference 2023, 19–24 May, Washington DC, USA.  

 

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Posted on 12 June 202313 June 2023