Verona Pharma, the biotechnology company dedicated to discovering new drugs for the treatment of chronic respiratory diseases, has successfully completed a further phase II study to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma.

The trial, which took place at the Centre for Human Drug Research (CHDR) at Leiden, The Netherlands, treated 12 patients with mild asthma with daily doses of RPL554 for a period of 6 days. The patients were tested every day but the major observations on bronchodilation were on days 1, 3 and 6 when measurements were continued for 6 hours. The  assessment of bronchodilation was based on FEV1 (forced expiratory volume at 1 second), a common method used to evaluate the bronchodilator effects of drugs. The trial was a single blind, randomised, placebo-controlled trial.

The trial successfully demonstrated that RPL554 had sustained bronchodilator actions throughout the treatment period. There was no accumulation of the drug in plasma and no safety issues were observed.  There was a minor increase in heart rate at day 6 only, being the last day of treatment. This is the third trial with RPL554 in patients with allergic asthma. The second trial, recently completed at the CHDR in February 2011, established the effectiveness of higher doses of the drug. A further trial currently being planned to test the anti-inflammatory actions of RPL554 is expected to start later this year.

Michael Walker, CEO of Verona Pharma, said: “The clinical studies performed so far with RPL554 have defined the actions of our drug in terms of doses that are safe and produce a clear and unequivocal bronchodilator effect. This bronchodilator effect is of value in the treatment of asthma, and possibly Chronic Obstructive Pulmonary Disease (COPD). The sustained bronchodilator effect of RPL554 throughout the treatment period is an important finding, and one that we will use when selecting the dosing regimen for a further trial we are currently planning to
demonstrate unequivocally the anti-inflammatory actions of RPL554.”

During this time when licensing efforts continue with RPL554 the Company is conducting further clinical trials to broaden its knowledge of the therapeutic usefulness of RPL554 in asthma and COPD and thereby  add value to the overall RPL554 licensing package. If the proposed antiinflammatory trial is successful, RPL554 will have a therapeutic profile as the first of a new class of drugs for the treatment of both asthma and COPD; common diseases with significant markets that are in need of new drugs.