Verona Pharma: Start of RPL554 Phase IIa combination study

Verona Pharma plc , the drug development company focused on first-in-class medicines to treat respiratory diseases, has announced that the first patients have been dosed in a Phase IIa combination study to evaluate the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disease (COPD).

The company explained that RPL554 is a novel inhaled PDE3/PDE4 inhibitor with anti-inflammatory as well as bronchodilatory properties, currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. The nebulised bronchodilator market was worth approximately $1 billion in 2014 in the US.

The primary objective of this study is to evaluate whether RPL554 has an additive bronchodilator effect in COPD patients, when administered in addition to standard of care bronchodilators. Up to 30 patients will be enrolled in this double-blind, placebo-controlled, six way crossover study, which will investigate the pharmacodynamic effect of nebulised RPL554 in a commercially scalable suspension formulation. This trial will use spirometry2 and whole body plethysmography3 to compare RPL554 to placebo, when administered with a beta2 agonist (salbutamol), and with a muscarinic antagonist (ipratropium), said the company.

The trial is being performed at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh.

As reported on 29 September 2015, Phase IIa results from a prior study using nebulised RPL554 alone in stable COPD patients with moderate severity of disease, showed that, in addition to good tolerability and safety profile, RPL554 caused a pronounced improvement in lung function, as measured by peak FEV1, suggesting the drug produced a clinically meaningful bronchodilator effect.

Dr Jan-Anders Karlsson, the CEO of Verona Pharma, said:

“We believe RPL554 has the potential to become an important new treatment option for COPD patients. This latest study will evaluate the potential of RPL554 when added to existing therapies. We recently announced encouraging results from our standalone Phase IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 is well tolerated and has allowed us to extend the dose range and the duration of bronchodilation effect that can be produced in COPD patients. Headline data from this combination study is expected in Q2 2016.
“We are also evaluating the potential of RPL554 in a Phase IIa trial in asthma patients and look forward to reporting headline data in Q1 next year.”