UK-based biopharmaceutical firm Verona Pharma has begun dosing patients in a Phase IIb clinical trial of RPL554 as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
RPL554 is an inhaled, dual inhibitor of phosphodiesterase 3 and 4 enzymes currently being developed to act as bronchodilator, as well as anti-inflammatory agent for COPD and cystic fibrosis treatment.
The dose-ranging, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy, safety, and dose-response of nebulised RPL554 over four weeks in 400 subjects across multiple European centres.
Improvement in lung function will be measured as the trial’s primary endpoint using a standard exhaled breath volume measure called FEV1 to assess respiratory function.
The top-line results from the trial are estimated to be available in the second half of next year.
Verona Pharma CEO Jan-Anders Karlsson said: “Dosing our first patients in this larger four-week Phase IIb trial is an important step forward in the evaluation of nebulised RPL554 as a novel therapy for COPD patients with significant unmet medical needs.
“The clinical data generated to date and the mechanism of action of RPL554 makes it a promising first-in-class treatment option.”
The Phase IIb trial is being conducted as part of the firm’s global strategic services agreement with QuintilesIMS for core clinical trial services and insights on development and commercial strategy.
RPL554 was found to be well-tolerated and demonstrated anti-inflammatory effects in prior trials.
During these trials, the investigational candidate indicated a clinically meaningful and statistically significant improvement in lung function upon administration, in combination with two common bronchodilators.