Merck has initiated the phase 3 ENHANCE-3 clinical trial to evaluate ensifentrine, an FDA-approved COPD maintenance treatment, for preventing exacerbations in approximately 2,136 adults across 28 countries over 52 weeks.
- Study Name: ENHANCE-3, Merck's phase 3 trial for ensifentrine (MK-5884) in COPD patients
- Primary Goal: Evaluate ensifentrine's ability to reduce the annualized rate of moderate or severe COPD exacerbations over 52 weeks
- Enrollment: Approximately 2,136 patients from 28 countries with a history of moderate to severe exacerbations
- Secondary Endpoints: Lung function improvement (FEV1), quality of life measures, and severe exacerbation prevention
- Prior Approval: Ensifentrine received FDA approval in June 2024 as a maintenance treatment based on ENHANCE-1 and ENHANCE-2 studies
Pharmaceutical company Merck is moving ahead with a phase 3 study evaluating ensifentrine (brand name: Ohtuvayre) for the prevention of COPD exacerbations in adult patients receiving standard of care with a history of exacerbations.
The company said in a press release that recruitment has begun for the trial, “Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease Exacerbations in Adults With a History of Moderate to Severe Exacerbations While Receiving Enhanced Care (ENHANCE-3).”
In addition to evaluating ensifentrine compared to placebo for the prevention of COPD exacerbations, the study will also evaluate the efficacy of ensifentrine compared with placebo for improving lung function and health-related quality of life and preventing severe exacerbations.
The primary endpoint is the annualized rate of adjudicated moderate or severe COPD exacerbations over 52 weeks. Secondary endpoints include:
- Any change from baseline FEV1 area under the curve from 0-4 hours
- Any change from baseline in St. George’s Respiratory Questionnaire total score responder status
- The annualized rate of adjudicated severe COPD exacerbations over 52 weeks
- The number of participants with at least one adverse event up to 52 weeks
- The number of participants who discontinue study intervention due to an adverse event
Researchers plan to enroll approximately 2,136 patients from 28 countries in the study.
Mahesh Patel, MD, vice president of global clinical development for Merck Research Laboratories, said the trial could provide hope for COPD patients who continue to experience persistent symptoms such as shortness of breath, despite standard-of-care therapy.
“The initiation of the phase 3 ENHANCE-3 study marks an important step in our efforts to further strengthen the body of evidence supporting (ensifentrine) and its potential to address significant unmet needs in COPD care,” he said. “We remain committed to advancing innovative research to help the millions of people impacted by this disease worldwide.”
Ensifentrine was approved by the U.S. Food and Drug Administration in June 2024 as a maintenance treatment in adults with COPD. This approval was based on the ENHANCE-1 and ENHANCE-2 studies.
