All of the primary and secondary lung function endpoints were met in a Phase II trial for Verona’s dry powder inhaler (DPI) formulation of its lead development product, ensifentrine, for the maintenance treatment of chronic obstructive pulmonary disease (COPD), the company has reported.
The treatment showed highly statistically significant and clinically meaningful dose-dependent improvement in lung function, with secondary data supporting twice daily dosing and showing that ensifentrine was well tolerated at all dose levels.
Verona announced positive results from the first part of the trial in March, which demonstrated a single dose of ensifentrine produced a statistically significant and clinically meaningful dose-dependent bronchodilator response.
This included increased lung function as measured by forced expiratory volume in one second compared to placebo, as well as 12-hour duration of action. The trial consisted of 37 patients with moderate-to-severe COPD, who received a single dose of either the drug or a placebo.
“Achieving a bronchodilator response of this magnitude in COPD patients is clinically meaningful and very encouraging,” commented Joseph A Boscia, pulmonary physician and principle investigator at Vitalink Research-Union, South Carolina. “This highlights the potential for ensifentrine’s unique mechanism of action to provide lung function improvement and meet the urgent clinical need for new treatments for patients with this progressive and debilitating disease."
In addition to the DPI formulation of ensifentrine, Verona Pharma is developing a pressurised metered-dose inhaler (pMDI) formulation of ensifentrine and expects to report initial single dose data using this widely used handheld inhaler format in the second half of 2019.