Merck Initiates Its ENHANCE-3 Phase 3 Randomized Clinical Trial Evaluating OHTUVAYRE For The Prevention Of Chronic Obstructive Pulmonary Disease
Benzinga Newsdesk 10 hours ago
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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
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 U.S. Food and Drug Administration (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.