Merck has launched a global Phase 3 clinical trial to assess whether its COPD drug OHTUVAYRE (ensifentrine) can prevent disease exacerbations in adults who continue to experience flare-ups despite receiving standard treatment.

 

The pharmaceutical major announced the start of ENHANCE-3 on November 3, with patient recruitment already under way in the United States. The study will enrol approximately 2,136 patients across 28 countries and evaluate the drug's potential to reduce moderate and severe COPD exacerbations.

 

The trial marks a significant step in Merck's efforts to expand the clinical evidence supporting OHTUVAYRE, particularly among patients who remain vulnerable to recurring exacerbations despite existing therapies.

 

“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 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.”

 

COPD is a progressive respiratory disease characterised by restricted airflow and persistent breathing difficulties. Exacerbations, or sudden worsening of symptoms, can accelerate disease progression, impair quality of life and increase the burden on healthcare systems.

 

Despite available treatments, many patients continue to experience symptoms such as breathlessness, coughing, wheezing and chest tightness. Smoking and air pollution are among the leading causes of the disease.

 

ENHANCE-3 will investigate whether adding OHTUVAYRE to existing standard-of-care treatment can reduce the frequency of moderate or severe exacerbations over 52 weeks.

 

The primary endpoint is the annualised rate of adjudicated moderate or severe COPD exacerbations. Secondary measures will assess lung function, health-related quality of life, severe exacerbations and safety.

 

The study will involve adults with a history of at least one moderate or severe exacerbation in the previous year despite receiving standard treatment. Eligible participants will be randomly assigned to receive OHTUVAYRE twice daily alongside standard therapy or a placebo alongside standard therapy.