Merck has initiated ENHANCE-3, a Phase 3 randomized trial evaluating OHTUVAYRE (ensifentrine) for the prevention of COPD exacerbations in adult patients receiving standard of care with a history of exacerbations. Recruitment has begun, and the first patients are enrolling in the United States.
The trial plans to enroll approximately 2,136 patients across 28 countries. Participants must have a confirmed diagnosis of COPD for at least 12 months, a current or former smoking history, use of the same standard of care for at least two months, and a documented history of at least one moderate or severe COPD exacerbation within the year prior to enrollment. Standard of care is defined as long-acting muscarinic antagonists, long-acting beta-agonists and inhaled corticosteroids, or LAMA and LABA if ICS is not appropriate. Participants will be randomized 1:1 to receive OHTUVAYRE twice daily plus standard of care or placebo plus standard of care.
The primary endpoint is the annualized rate of adjudicated moderate or severe COPD exacerbations over 52 weeks. Secondary endpoints include change from baseline in FEV1 AUC0-4h at week 12, responder status on the St. George's Respiratory Questionnaire at week 24, the annualized rate of adjudicated severe COPD exacerbations over 52 weeks, and overall safety.
Dr. Mahesh Patel, vice president, global clinical development, Merck Research Laboratories, said exacerbations remain a major driver of disease progression and diminished quality of life for patients who remain symptomatic despite standard-of-care therapy.
OHTUVAYRE was approved by the FDA in June 2024 for maintenance treatment of COPD in adults based on the ENHANCE-1 and ENHANCE-2 studies. It is also being evaluated in a Phase 2 trial for non-cystic fibrosis bronchiectasis.
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