UK-based Verona Pharma has launched a pilot study to assess ensifentrine administered via a pressurised metered-dose inhaler (pMDI) formulation in US patients hospitalised with Covid-19.
Ensifentrine is known to exhibit bronchodilator and anti-inflammatory activities.
Data from clinical studies in other respiratory diseases demonstrated that the drug improved oxygenation and mucus clearance, as well as reduced inflammation in the lungs.
Verona Pharma added that the drug was well tolerated in trials involving more than 1,300 participants to date.
Verona Pharma president and CEO David Zaccardelli said: “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.”
The randomised, double-blind, parallel group pilot study will investigate the safety and efficacy of pMDI ensifentrine plus standard of care compared to standard of care plus placebo.
During the study, investigators will track the drug’s effect on key outcomes, including recovery from the infection, clinical status improvement, reduction in supplemental oxygen use, and progression to mechanical ventilation.
The study will enrol about 45 hospitalised Covid-19 patients at the University of Alabama in Birmingham, US. Participants will be given 2mg of pMDI ensifentrine or placebo twice-daily for up to 29 days or until discharge if prior to 29 days.
The primary endpoint is the proportion of patients who recovered from Covid-19 and were no longer hospitalised at day 29.
Last month, Verona Pharma started the multiple dose part of a Phase II trial of a pMDI formulation of ensifentrine to treat moderate to severe chronic obstructive pulmonary disease (COPD).