Verona Pharma has commenced a Phase ll clinical trial to evaluate the efficacy and safety of nebulised RPL554 as an add-on to treatment with dual long-acting anti-muscarinic/long-acting beta2-agonist drugs (LAMA/LABA) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
The randomised, double-blind, three-way crossover trial has already enrolled and dosed the first patients.
The trial, which is currently being conducted at several sites in the US and the UK, will enrol around 75 patients with COPD.
During the trial, the patients receiving inhaled corticosteroid (ICS) anti-inflammatory therapy will continue to receive a stable dose of ICS to provide additional data on ‘triple therapy’ use.
After completing a seven-to-14-day washout period in advance of dosing and between study arms, the patients will receive three days of treatment each with two doses of 1.5mg or 6.0mg of nebulised RPL554 or placebo twice daily.
The trial’s primary endpoint is improvement in lung function with RPL554 against placebo, as measured by peak forced expired volume in one second (FEV), a standard measure of exhaled breath volume to evaluate respiratory function.
Top-line data from the study is expected to be released by the first quarter of next year.
Verona Pharma CEO Jan-Anders Karlsson said: “We have already demonstrated that RPL554 is an effective add-on treatment to short and long-acting bronchodilators in COPD patients.
“This Phase ll trial will now examine the effect of RPL554 as an add-on to LAMA/LABA therapy, and in some patients to triple therapy, as many of these COPD patients continue to experience breathing difficulties and daily symptoms that impair their quality of life despite concomitant treatment with two bronchodilators.
“We believe the bronchodilator and anti-inflammatory properties of RPL554 may be particularly useful in this large group of patients with high unmet medical need.”
Verona Pharma expects to use data from the Phase ll trial to design the pivotal Phase ll studies of RPL554, which is scheduled to begin later next year.