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First COPD Trial with RPL554 Begins in Rome

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Verona Pharma plc has commenced a new trial with its lead respiratory drug, RPL554, in patients with chronic obstructive pulmonary disease (COPD).

This Phase II trial is taking place at University of Tor Vergata in Rome, and is designed to evaluate the safety and efficacy of RPL554 in patients with mild to moderate forms of COPD. The trial is being performed as an open label trial to observe the bronchodilator effects of the drug in COPD patients.

Such patients often have concomitant cardiovascular disease and are older and thus at a greater risk of potential adverse effects than were the younger asthmatic patients who were studied in the previous two reported trials of RPL554 carried out at the Centre for Human Drug Research (CHDR) in The Netherlands.

The measurements of interest in the trial are the standard measure of FEV1 (Forced Expiratory Volume in 1 sec) to test the effect of RPL554 on lung function, and blood pressure and electrocardiography (ECG) to test the safety of the drug in this patient group. The drug will be given in a nebulized form as was the case in the previous trials.

RPL554 is a novel long acting inhibitor of phosphodiesterase 3 and phosphodiesterase 4, two enzymes known to be of importance in a range of inflammatory respiratory diseases, and RPL554 is a drug that has been shown experimentally to have both anti-inflammatory and bronchodilator actions. The bronchodilator actions have been shown repeatedly in the previous CHDR trials referred to above.

Professor Michael Walker, CEO of Verona Pharma said: “COPD is an obvious disease target for RPL554’s bronchodilator and potential anti-inflammatory actions. COPD is increasingly prevalent throughout the world and existing drugs fail to provide effective treatment for the disease. We are extending our clinical trials of RPL554 to include COPD since its mechanism of action is directly applicable to this disease. Positive results from this trial are expected to add therapeutic and financial value to RPL554.”