Dual Bronchodilator and Anti-Inflammatory COPD Drug Offers Potential for COVID-19 Treatment

Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown that ensifentrine improved oxygenation, reduced inflammation in the lungs and enhanced mucus clearance. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people to date.

In earlier clinical trials, ensifentrine has shown pronounced bronchodilator effects in healthy subjects and in patients with COPD or asthma. Verona has now initiated a pilot study to investigate the efficacy and safety of ensifentrine delivered via pressurized metered-dose inhaler (pMDI) formulation in patients hospitalized with COVID-19. The study will evaluate the effect of ensifentrine on key outcomes in patients hospitalized with COVID-19 including facilitation of recovery from the viral infection, clinical status improvement and reduction in supplemental oxygen use and progression to mechanical ventilation. The randomized, double-blind, parallel group pilot study will evaluate the efficacy and safety of pMDI ensifentrine added on to standard of care treatment in patients with COVID-19 compared to standard of care plus placebo.

“Therapies are urgently needed to treat patients hospitalized with COVID-19. Ensifentrine has demonstrated impressive effects on improving lung function and symptoms in patients with obstructive lung diseases, along with notable anti-inflammatory effects following inhaled dosing in clinical trials to date. Combined with positive safety results, ensifentrine has the potential to significantly benefit patients suffering from COVID-19,” said Mike Wells, MD, MSPH, a pulmonologist and Principal Investigator at the University of Alabama at Birmingham.

“The need for effective COVID-19 treatments to reduce the disease burden is clear and we believe ensifentrine, with its novel mechanism of action, could help to improve patient outcomes. If the pilot study is successful, we are committed to progressing ensifentrine as a treatment for COVID-19 and, if approved, increasing supplies to meet public health needs,” added David Zaccardelli, Pharm. D., President and CEO of Verona Pharma.

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