UK-based Verona Pharma has reported positive interim data from the two-part Phase II clinical trial of its ensifentrine dry powder inhaler (DPI) formulation to treat chronic obstructive pulmonary disease (COPD).
In the first part of the trial, 37 moderate-to-severe COPD patients treated with a single dose of the DPI formulation achieved statistically significant and clinically meaningful dose-dependent bronchodilator response, indicating improvement in lung function.
Five dosage strengths of 150µg, 500µg, 1,500µg, 3,000µg and 6,000µg were evaluated and found to be well tolerated. The adverse event profile was similar to that of placebo.
Ensifentrine is an investigational inhaled, dual inhibitor of the phosphodiesterase III and IV enzymes. It is designed to exhibit both bronchodilator and anti-inflammatory properties.
Verona Pharma CEO Jan-Anders Karlsson said: “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.”
The positive results from the first part of the trial support the start of the randomised, double-blind, placebo-controlled, multiple dose crossover second part to be conducted at a single US centre.
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Designed to assess twice daily ensifentrine DPI over one week, the second part’s primary endpoint is the bronchodilator effect of repeat doses.
Secondary objectives include safety, tolerability, bronchodilator profile and pharmacokinetics of repeat doses of ensifentrine administered by DPI.
Verona Pharma is also studying nebulised ensifentrine in Phase IIb clinical development and intends to conduct a Phase II trial of a pressurised metered-dose inhaler (pMDI) formulation in COPD patients.
The drug is also being developed for the treatment of patients with cystic fibrosis and asthma.