Merck starts Phase 3 ENHANCE-3 trial of Ohtuvayre to prevent COPD exacerbations
Merck, known as MSD outside of the United States and Canada, announced the initiation of ENHANCE-3 (NCT07874815), a Phase 3 randomized clinical trial evaluating OHTUVAYRE (ensifentrine) for the prevention of chronic obstructive pulmonary disease (COPD) exacerbations in adult patients receiving standard of care (SOC) with a history of exacerbations.
Recruitment of the ENHANCE-3 trial has begun, and the first patients are now enrolling in the United States.
“Many patients with COPD continue to experience persistent symptoms such as shortness of breath, despite current standard-of-care therapy. For these patients, exacerbations remain a major driver of disease progression and diminished quality of life,” said Dr. Mahesh Patel, vice president, global clinical development, Merck Research Laboratories. “The initiation of the Phase 3 ENHANCE-3 study marks an important step in our efforts to further strengthen the body of evidence supporting OHTUVAYRE and its potential to address significant unmet needs in COPD care. We remain committed to advancing innovative research to help the millions of people impacted by this disease worldwide.”
The ENHANCE-3 Phase 3 trial plans to enroll approximately 2,136 patients in 28 countries across the world. The primary endpoint of the study is the annualized rate of adjudicated moderate or severe COPD exacerbations, and secondary endpoints include lung function, health-related quality of life, severe exacerbations and safety. We look forward to sharing the results of the ENHANCE-3 trial with regulatory authorities globally.
Based on the ENHANCE-1 and ENHANCE-2 studies, OHTUVAYRE was approved by the FDA in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is the first and only novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years to combine bronchodilation and non-corticosteroid anti-inflammatory effects. OHTUVAYRE is also being evaluated in a Phase 2 clinical trial for the treatment of non-cystic fibrosis bronchiectasis.
About ENHANCE-3 (NCT07874815)
ENHANCE-3 is a Phase 3, randomized, double-blind, placebo-controlled study evaluating approximately 2,136 patients with a history of at least one moderate or severe COPD exacerbation in the previous year while receiving standard of care (SOC), defined as long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA) and inhaled corticosteroids (ICS), or LAMA and LABA if ICS is not appropriate. Participants will be randomized 1:1 to receive OHTUVAYRE twice daily plus SOC or placebo plus SOC. The primary endpoint is the annualized rate of adjudicated moderate or severe COPD exacerbations over 52 weeks. The secondary endpoints are the change from baseline in FEV1 (forced expiratory volume in one second, a standard measure of lung function) AUC0-4h (area under the curve, 0-4 hours post-dose) at week 12, responder status on the SGRQ (St. George’s Respiratory Questionnaire, a measure of health-related quality of life in COPD) at week 24, the annualized rate of adjudicated severe COPD exacerbations over 52 weeks, as well as overall safety.
Key eligibility criteria for the trial include adults 40 to 80 years of age with a confirmed diagnosis of COPD for at least 12 months, a current or former smoking history, use of the same SOC for at least two months, and a documented history of at least one moderate or severe COPD exacerbation within the year prior to enrollment.
