15-11-2011: Verona Pharma plc has successfully demonstrated in a Phase IIa RPL554 study bronchodilator effects in patients with chronic obstructive pulmonary disease (“COPD”).
The pilot Phase IIa study was carried out by a world leading expert on COPD, Professor Mario Cazzola at the Tor Vergata Polyclinic, University of Rome. The study involved administering nebulized RPL554 as a single dose of 0.018 mg/kg to patients with COPD. The study met its primary endpoint by showing that the drug produced a significant improvement in lung function of up to a 10% increase in FEV1 (forced expiratory volume at 1 second) as compared with placebo. FEV1 is a standard method used to evaluate the bronchodilator effects of drugs. In addition, the duration of action observed was similar to that previously seen with RPL554 in patients with asthma.
Overall, RPL554 was well tolerated and no cardiovascular or other safety issues were observed, despite COPD being a condition in which concurrent cardiovascular disease is common.
Referring to the pilot trial, Professor Cazzola commented, “The extent of bronchodilation, plus the absence of any side effects with RPL544, are very encouraging and show that the drug has potential to be a significant new class of bronchodilators for the treatment of COPD. Many existing bronchodilator drug treatments for COPD produce side effects due to the cardiovascular and other health issues relating to the disease.”
This successful pilot study, which is the first trial with RPL554 in patients with COPD, will be expanded to incorporate more patients so as to provide further safety data for the ongoing development of RPL554 as a treatment for COPD and other respiratory diseases.
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