Verona Pharma completed a Phase 2 study to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma.
The trial took place at the Center for Human Drug Research (CHDR) and treated 12 patients with mild asthma with daily doses of RPL554 for a period of 6 days. The patients were tested daily 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, randomized, placebo-controlled trial.
The trial 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 established the effectiveness of higher doses of the drug. A further trial is being planned to test the anti-inflammatory actions of RPL554 and is expected to start later in 2011.
“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,” says Michael Walker, chief executive officer of Verona Pharma.
Release Date: August 17, 2011
Source: Verona Pharma
Filed Under: Drug Discovery