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On October 9, 2024, we reported on a new post-hoc analysis of the pivotal phase 3 ENHANCE clinical trials presented at the CHEST 2024 Annual Meeting.
The study
The ENHANCE registration trials evaluated nebulized ensifentrine 3 mg twice daily in patients aged 40 to 80 years with symptomatic, moderate-to-severe COPD (FEV1 30% to 70% predicted, mMRC dyspnea score ≥2, and a ≥10 pack-year smoking history). Ensifentrine is a novelfirst-in-class dual phosphodiesterase three and phosphodiesterase 4 inhibitor that was approved by the FDA in June 2024.
A total of 868 participants with COPD with moderate airflow obstruction and 681 with severe airflow obstruction who were permitted to be remain on background maintenance bronchodilator therapy were enrolled in the ENHANCE trials. The primary endpoint was change from baseline to week 12 in average FEV1 AUC (0-12h).
The post-hoc analysis presented at CHEST 2024 further evaluated lung function, symptoms, and QoL in subgroups of patients with moderate (≤50% baseline FEV1 <80% predicted) and severe (30% ≤ baseline FEV1 <50% predicted) airflow obstruction.
The findings
Use of ensifentrine was associated with a statistically significant improvement in FEV1 AUC (0-12h) relative to placebo at week 12 for both the moderate and severe subgroups (P < .05). The researchers also found that treatment with ensifentrine yielded significant improvement in peak FEV1 after 12 weeks in both groups (P < .05) vs placebo.
Treatment with ensifentrine also was associated with statistically significant improvement from baseline in symptoms reflecting QoL in both the moderate and severe airflow obstruction groups.
Authors' comment
"Patients with COPD continue to suffer from impaired lung function, daily symptoms, and impaired quality of life despite available treatments. Ensifentrine provides a novel mechanism of action for clinically meaningful improvements in lung function, symptoms, and quality of life regardless of COPD severity, that is complementary to existing treatment mechanisms."
