Verona Pharma has announced positive interim efficacy and safety results from an evaluation of a dry powder inhaler (DPI) formulation of ensifentrine in moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Part one of the Phase II trial 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.
The treatment, also known as RPL554, is an investigational first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase three and four designed to have bronchodilator as well as anti-inflammatory properties.
“The large bronchodilator response, 12-hour duration of action and good tolerability observed with the DPI ensifentrine formulation in the first portion of this study are very encouraging and we look forward to proceeding with the second part to evaluate treatment over a one-week period,” said Jan-Anders Karlsson, PhD, Chief executive of Verona Pharma.
He continued, “Positive data from this and future studies with inhaler formulations could dramatically expand the clinical utility and commercial opportunity for ensifentrine not only in the treatment of COPD, but potentially in other respiratory diseases such as asthma.”
An estimated 5.5 million people in the US alone use inhalers for the maintenance treatment of COPD.