UK-based biopharmaceutical firm Verona Pharma has secured regulatory approval to start a Phase IIb clinical trial of RPL554 in patients with chronic obstructive pulmonary disease (COPD) in the UK, Germany, Romania, Bulgaria and the Czech Republic.
Being developed to treat COPD and cystic fibrosis, RPL554 is a dual inhibitor of the enzymes phosphodiesterase 3 and 4 and possess both anti-inflammatory and bronchodilator properties.
The double-blind, parallel group, placebo-controlled, four-week, dose-ranging Phase IIb trial is designed to evaluate the efficacy, safety and dose-response of nebulised RPL554 as a maintenance treatment in up to 400 subjects.
Verona Pharma CEO Jan-Anders Karlsson said: "This dose escalation trial directly supports our ongoing development plans for RPL554 and we look forward to enrolling patients in these, and potentially additional countries, subject to further approvals.
"This four-week, 400-patient study is an important step forward in evaluating the potential of RPL554 as a promising first-in-class treatment option for the 210 million people around the world who suffer from COPD on an ongoing basis."
The trial is set to be commenced in the third quarter of this year, while its primary endpoint is improvement in lung function as measured by FEV1, when compared to placebo.
The dose-escalation trial is part of the firm’s global strategic services agreement with QuintilesIMS for core clinical trial services of RPL554 clinical development programmes, as well as development and commercial strategy.
Top-line results from the trial are estimated to be available in the second half of next year.