The U.S. Food and Drug Administration has approved ensifentrine for the treatment of COPD, a first-in-class therapy. Ensifentrine acts by blocking two lung proteins that cause muscle contraction in the airway and inflammation.
The approval was based on results from two phase 3 clinical trials, ENHANCE-1 and ENHANCE-2, which demonstrated significant improvements in lung function and reductions in COPD exacerbations compared with placebo at 24 weeks.
The trials were conducted between September 2020 and December 2022 at 250 research centers and pulmonology practices in 17 countries, and included patients aged 40-80 years with moderate to severe symptomatic COPD.
In the ENHANCE-1 trial of 760 study participants, and the ENHANCE-2 trial of 789 participants, ensifentrine met the primary endpoint of improved forced expiratory volume in 1 second (FEV1), a key measure of lung function.
After 12 weeks of treatment, patients treated with ensifentrine experienced improvements in FEV1 by 87 mL in ENHANCE-1 and by 94 mL in ENHANCE-2. Secondary endpoints, included improvements in quality of life and symptom relief, were significantly achieved in ENHANCE-1 but not in ENHANCE-2. Notably, 69% and 55% of patients received concomitant long-acting muscarinic antagonists or long-acting β2-agonists, respectively.
"The findings of the ENHANCE studies are almost overwhelmingly positive, showing that ensifentrine provides bronchodilation associated with meaningful clinical benefits," noted study investigators in the published results.
Adverse event rates were similar to those for placebo, indicating a favorable safety profile.