CHEST 2024: Ensifentrine Improves Lung Function, Quality of Life Regardless of COPD Severity

Jessica Bon, MD, MS
Credit: LinkedIn

New research presented at CHEST 2024 suggests ensifentrine (Ohtuvayre) was associated with improved lung function, symptoms, and quality of life regardless of disease severity among patients with chronic obstructive pulmonary disease (COPD).

“Patients with COPD continue to suffer from impaired lung function, daily symptoms, and impaired quality of life despite available treatments,” wrote investigators.¹ “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.”

In June 2024, ensifentrine received a historic approval from the US Food and Drug Administration for the maintenance of COPD. An inhaled nonsteroidal nebulizer therapy, the dual PDE3 and PDE4 inhibitor became the first treatment with a novel mechanism of action to receive approval for COPD in more than a decade. This approval, which was awarded to Verona Pharma, was based on data from the phase 3 ENHANCE-1 and -2 trials.²

In her presentation at CHEST 2024, Jessica Bon, MD, MS, of Wake Forest University School of Medicine, detailed an analysis of the trials aimed at detailing the effects of the agent on lung function, COPD symptoms, and quality of life among patients with moderate-to-severe COPD. Form the trials. Investigators obtained information from 868 patients with COPD and moderate airflow obstruction and 681 with severe airflow obstruction.¹

Upon analysis, results suggested 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). Further analysis demonstrated ensifentrine treatment was associated with significantly improved Peak FEV1 at week 12 relative placebo in both groups (P <.05).¹

Investigators highlighted improvements observed in E-RS Total Score with ensifentrine, with this reduction reaching statistical significance relative to placebo therapy at weeks 6, 12, and 24 among the moderate subgroup (P <.05) and week 6 among the severe subgroup. Of note, numeric improvements were observed in the severe group at weeks 12 and 24. Additionally, analysis of St. George’s Respiratory Questionnaire total scores suggested improvements in score were observed at weeks 6, 12, and 24 for both subgroups and exceeded the minimal clinically important difference at weeks 6 and 24 in both subgroups.¹

In addition to this analysis, 5 other presentations focused on the effects of ensifentrine at CHEST 2024. These studies, all of which leveraged data from the ENHANCE program, examined the effects across a multitude of subgroups and for several different endpoints, including quality of life, effect of background smoking history on outcomes, and associations of use with decreasing healthcare resource utilization.³

“Ensifentrine is a remarkable addition to COPD therapy,” said William Stringer, MD, professor of Medicine at the David Geffen School of Medicine at UCLA.³ “It has the capacity to bronchodilate, reduce inflammation, augment mucociliary clearance, and reduce exacerbations in smokers and former smokers.”

References:

1. Bon JM, Rheault T, Rickard KA, et al. ENSIFENTRINE IMPROVED LUNG FUNCTION, SYMPTOMS, AND QUALITY OF LIFE REGARDLESS OF COPD SEVERITY. Presented at: CHEST 2024. Boston, MA. October 6 - 9, 2024.
2. Kunzmann K. FDA approves Ensifentrine (ohtuvayre) for COPD. HCP Live. June 26, 2024. Accessed October 8, 2024. https://www.hcplive.com/view/fda-approves-ensifentrine-for-copd.
3. Verona Pharma. Verona Pharma to present six analyses of the phase 3 enhance studies in COPD at chest 2024. Verona Pharma. September 30, 2024. Accessed October 8, 2024. https://www.veronapharma.com/news/verona-pharma-to-present-six-analyses-of-the-phase-3-enhance-studies-in-copd-at-chest-2024/.