Verona Pharma has reported positive data from a pilot study evaluating a pressurised metered-dose inhaler (pMDI) formulation of ensifentrine to treat Covid-19.
Data from the double-blind, placebo controlled, unpowered study showed that the first-in-class product candidate ensifentrine was safe and well-tolerated in patients infected with SARS-CoV-2 virus that causes Covid-19.
The trial, which randomised 30 patients to receive ensifentrine and 15 to placebo, has not been designed or sized to demonstrate clinical efficacy and was conducted at the University of Alabama .
It evaluated inhaled ensifentrine on key outcomes in Covid-19 patients when added on to standard of care therapies, which included remdesivir and dexamethasone.
In the study, no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed. In the ensifentrine treatment group, one patient death was reported.
The study participants received 2mg of pMDI ensifentrine or placebo twice-daily for up to 29 days or until discharge if this occurred before 29 days.
Their clinical status was evaluated on a daily basis until discharge and at days 29 and 60.
University of Alabama at Birmingham Hospital pulmonologist and principal investigator Mike Wells said: “Overall, the patients in this study recovered exceptionally well, as the mortality rate in the study was much lower than aggregate data from the hospital would have suggested over the same time period.”
Proportion of patients recovered (not hospitalised) from Covid-19 over 29 days formed the primary endpoint of the study.
Safety and tolerability, time to recovery, proportion of patients with 1- and 2-point improvement on an ordinal scale are the other endpoints in addition to proportion of patients progressing to mechanical ventilation, duration of hospitalisation, duration and incidence of oxygen use, re-hospitalisation, and mortality.
With both bronchodilator and anti-inflammatory activities in one compound, ensifentrine is currently being studied in Phase III clinical development for the treatment of Chronic Obstructive Pulmonary Disease.
It has been well tolerated in clinical trials which involved more than 1,300 participants.