Verona Pharma has completed patient enrolment for the Phase IIa dose-finding study of RPL554 in asthma and the Phase IIa combination study of RPL554 in chronic obstructive pulmonary disease (COPD), in which the drug is being administered in addition to standard of care bronchodilators.
The the drug development company focused on first-in-class medicines to treat respiratory diseases, in its announcement on Thursday said that Headline data is expected Q1 2016 for the asthma study and Q2 2016 for the COPD combination study.
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 company said.
Furthermore, 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 are very pleased to have completed recruitment in both of these studies ahead of our plan. We believe the results will continue to build on the positive data recently announced from our Phase I/IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 is well tolerated and that the extent of the bronchodilation exceeded that seen in earlier studies with the prior formulation.
We believe RPL554 has the potential to become an important new treatment option for both COPD and asthma patients and look forward to reporting headline data from both studies in the first half of next year.”
Verona Pharma, explaining the studies said that in Phase IIa study of RPL554 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 previously tested in the Phase Ib single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects.
In this double-blind, placebo-controlled, crossover study, each patient will also receive two different doses of nebulised salbutamol, a commonly used bronchodilator in these patients, and placebo. The primary objective of the trial is to establish the dose-dependency of the bronchodilator effect and the duration of action of RPL554 in asthma patients. The study is being performed at Celerion (Belfast, Ireland) and Skane University Hospital (Lund, Sweden).
As for Phase IIa combination study of RPL554 in COPD patients the company said that the primary objective was to evaluate whether RPL554 has an additive bronchodilator effect and is well tolerated in COPD patients, when administered in addition to standard of care bronchodilators.
The company said that thirty patients have been 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).
The trial is being performed at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh, Verona Pharma concluded.