Verona Pharma plc has announced the completion and reporting of data from a clinical trial with its lead drug candidate, the dual PDE 3 and 4 inhibitor RPL554, in patients with chronic obstructive pulmonary disease (COPD).
The data was presented by the trial’s Principal Investigator, Professor Mario Cazzola, at the European Respiratory Society (ERS) Annual Congress in Vienna.
The Phase II trial was a placebo-controlled cross-over study in 12 patients with mild to moderate COPD and was carried out at the Tor Vergata Clinic at the University of Rome, Italy.
The data showed that a single dose of nebulized RPL554 to patients with COPD produced a rapid bronchodilator response, greater than a 15% increase in FEV1 (forced expiratory volume at 1 second).
This magnitude of bronchodilator response was significantly larger than that produced by placebo and appeared to be at least equivalent to that produced by a standard dose of the reference bronchodilator beta2-agonist salbutamol in these patients.
In addition, inhalation of 0.018 mg/kg of RPL554 was well tolerated and did not cause any significant adverse effects.
Professor Cazzola commented: “Our results with RPL554 show that this is a promising novel class of bronchodilator drug for the treatment of asthma and COPD.”
This completes the first bronchodilator study in mild to moderate COPD patients at the Tor Vergata Clinic in Rome and is an expansion of the pilot part of the study announced by the Company on 10 November 2011.
Dr. Jan-Anders Karlsson, CEO of Verona Pharma said: “These data with RPL554 in COPD patients confirms the bronchodilator activity that we have previously observed in a smaller group of COPD patients and in asthmatics. RPL554 has a very interesting profile with its rapid onset of action. In addition to its bronchodilator activity, we are evaluating its potential anti-inflammatory effect in the clinical trial that is currently on-going at the Medicines Evaluation Unit in Manchester.”