Function

Ensifentrine safely and effectively improved lung function and reduced the rate and risk of exacerbations in COPD patients in a trial.

[completed enrollment early this year](https://copdnewstoday.com/news/verona-completes-enrollment-enhance-2-trial-ensifentrine-copd/), the mean age of its 790 participants was 65.1 years and 48.5% were male. Positive changes with ensifentrine were clinically meaningful for both measures, reaching statistical significance for daily symptoms in the earliest time points, but not at 24 weeks. FEV1, a common lung function measure, corresponds to the amount of air a person can forcibly exhale in one second. Also, about 15% received inhaled steroids in addition to a conventional bronchodilator. Ensifentrine was safe and well tolerated. Ensifentrine is a first-in-class inhaled therapy that works by blocking phosphodiesterase 3 and 4, two enzymes involved in muscle contraction and airway inflammation. In the U.S., such submission is anticipated in the first half of 2023. These subgroups included those divided by gender, age, smoking status, COPD severity, background medication, inhaled corticoid steroid use, chronic bronchitis, and geographic region. While affecting around 2% or fewer patients, COPD worsening, common cold, diarrhea, sinusitis, and high blood pressure, were more common in the ensifentrine group. “We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD,” Zaccardelli said. [ENHANCE-1 (NCT04535986)](https://www.clinicaltrials.gov/ct2/show/NCT04535986), are expected by year’s end. [The ENHANCE clinical program](https://copdnewstoday.com/news/verona-pharma-launches-phase-3-trials-evaluating-safety-efficacy-of-ensifentrine-in-copd/) was designed to evaluate the safety and effectiveness of ensifentrine against a placebo in about 1,600 adults, ages 40–80, with moderate to severe COPD (800 patients in each trial).