United Kingdom-based Verona Pharma has completed patient enrolment for a phase two trial for its nebulised RPL554 as an add-on to dual therapy using long-acting anti-muscarinic/long-acting beta2-agonists (LAMA/LABA) and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD), it was reported on Friday.
The company has enrolled a total of 79 patients with COPD in the United States and in the United Kingdom in this three way crossover study. It is expected that it will take several weeks to complete dosing.
Following data analysis, top line data is likely to be announced in January 2019. This randomised, double-blind, three-way crossover trial is designed to investigate the efficacy and safety of nebulised RPL554 as an add-on to an inhaled LAMA/LABA, tiotropium/olodaterol (Stiolto Respimat), compared to placebo. The primary endpoint of this trial is improvement in lung function with RPL554 vs placebo, as measured by peak forced expired volume in one second (FEV1), a standard measure of exhaled breath volume to evaluate respiratory function.
The product is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4, designed to have bronchodilator and anti-inflammatory properties, and is presently in development for the maintenance treatment of chronic obstructive pulmonary disease and for the treatment of cystic fibrosis.
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