Merck & Co (MSD) has begun the Phase III ENHANCE-3 clinical trial assessing Ohtuvayre (ensifentrine) to prevent exacerbations in adults with chronic obstructive pulmonary disease (COPD).
Patient recruitment has begun, with the initial participants enrolling in the US.
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The placebo-controlled, randomised, double-blind study plans to enrol around 2,136 patients across 28 countries.
Eligible participants are adults aged 40 to 80 years with a verified COPD diagnosis for at least 12 months, a current or previous smoking history, and a documented moderate or severe exacerbation within the prior year while receiving standard care.
Individuals must have received consistent background therapy for at least two months. Subjects will be randomised 1:1 to twice-daily Ohtuvayre or placebo alongside their existing standard-of-care regimen.
The primary endpoint assesses the annualised rate of adjudicated moderate or severe exacerbations over 52 weeks.
Secondary measures examine overall safety and adjudicated severe exacerbations over 52 weeks, and quality of life through the St George’s Respiratory Questionnaire (SGRQ) at week 24.
Permitted standard treatments include inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists, or bronchodilators alone if corticosteroids are inappropriate.
MSD Research Laboratories global clinical development vice-president Dr Mahesh Patel said: “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.
“The initiation of the Phase III 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 US Food and Drug Administration approved Ohtuvayre in June 2024 for adult COPD maintenance based on data from the ENHANCE-1 and ENHANCE-2 studies.
Last month, MSD reported that the Phase IIb MK-7240-012 study of its investigational humanised monoclonal antibody, tulisokibart, achieved its primary endpoint for patients with moderate to severe hidradenitis suppurativa.
