Shares of Verona Pharma (NASDAQ: VRNA) traded higher Tuesday after reporting positive results from its Phase 3 ENHANCE-1 trial that is currently evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
The company said that the ENHANCE-1 trial successfully met its primary and key secondary endpoints, demonstrating significant improvements in lung function, symptoms and quality of life measures.
Additionally, the company said that ensifentrine substantially reduced the rate and risk of COPD exacerbations and that ensifentrine was well tolerated over 24 and 48 weeks.
The study population of 763 subjects found that ensifentrine was effective in improving lung function and reducing the frequency of COPD exacerbations. Subject demographics and disease characteristics were evenly distributed among the treatment groups, and approximately 66% of subjects received background COPD therapy.
The primary endpoint, a change in lung function measured by FEV1, was met with a statistically significant improvement for subjects taking ensifentrine.
Additionally, key secondary endpoints of symptom improvement and quality of life also showed statistically significant improvements for the ensifentrine group. The drug was well-tolerated, with a favorable safety profile and few adverse events occurring in more than 1% of subjects.
In the ENHANCE-1 and ENHANCE-2 trials, subjects receiving ensifentrine experienced a 36% reduction in the rate of exacerbations over a 24-week period, compared to those receiving placebo (p=0.0505). The company says that this reduction was even more pronounced when data from both trials was pooled, with a 40% reduction in exacerbation rate observed (p=0.0012).
Ensifentrine also significantly decreased the risk of experiencing a moderate to severe exacerbation, as measured by time to first exacerbation, by 38% (p=0.0378) and 41% (p=0.0008) in the individual and pooled trials, respectively.
The company says that these results suggest that ensifentrine may be a promising treatment option for COPD patients and that additional information on the ENHANCE trials will be presented at upcoming conferences.
Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and non-steroidal anti-inflammatory activities in one compound. The drug is being studied as a potential treatment for COPD.
It is designed to improve lung function and reduce the frequency of COPD flare-ups. So far, it has shown promising results in clinical studies, with significant improvements in lung function, symptoms, and quality of life. It has also been well-tolerated in clinical trials involving over 3,000 subjects.
Shares of Verona Pharma trade on the NASDAQ under the ticker symbol VRNA. For more information visit www.veronapharma.com.
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