Verona Pharma completes patient enrolment in two RPL554 Phase IIa studies

RPL554 is the company’s lead drug, which is being evaluated in asthma and chronic obstructive pulmonary disease (COPD).

The drug is a novel inhaled PDE3/PDE4 inhibitor with anti-inflammatory and bronchodilatory properties. It is currently being developed as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting.

Headline data for both the studies is expected in the first and second quarters of 2016.

In the Phase IIa trial of asthma patients, 29 patients with mild to moderate persistent asthma will each receive single doses of nebulised RPL554, from the very low dose to the highest dose earlier tested in the Phase Ib single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects.

Each patient will also receive two different doses of nebulised salbutamol, a commonly used bronchodilator in these patients, and placebo.

The study intends to establish the dose-dependency of the bronchodilator effect and the duration of action of RPL554 in asthma patients.

The Phase IIa combination study of COPD patients will investigate the pharmacodynamic effect of nebulised RPL554 in a commercially scalable suspension formulation in 30 patients.

It will assess whether RPL554 has an additive bronchodilator effect and is well tolerated in COPD patients, when administered in addition to standard of care bronchodilators.