Verona Pharma PLC, a clinical stage biopharmaceutical company focused on the development of the best quality drugs for the treatment of respiratory diseases, announced the end of patient recruitment for two RPL554 studies, a Phase IIa study for asthma and Phase IIa combination study in chronic obstructive pulmonary disease (COPD).
Respiratory diseases are conditions that affect the air passages, including the nasal passages, the bronchi and the lungs. They can vary from acute infections, like pneumonia and bronchitis, to chronic conditions such as asthma and chronic obstructive pulmonary disease. In 2004, the WHO estimated that around 235 million and 64 million individuals had asthma and COPD, respectively.
RPL554 is Verona Pharma’s lead compound, a drug currently in Phase II trials as a nebulized treatment for acute exacerbations of COPD in a hospital and home-care setting. The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and has both bronchodilator and anti-inflammatory properties, which are crucial for the improvement of patients with COPD and asthma.
Phase IIa study of RPL554 in asthma will be performed in patients with mild to moderate persistent asthma to establish the dose-dependency of the bronchodilator effect and the period of action of RPL554 in these patients. The study is being performed at Celerion (Belfast, Ireland) and Skane University Hospital (Lund, Sweden).
The Phase IIa combination study of RPL554 will be performed in COPD patients, in which the drug will be administered in addition to standard of care bronchodilators. The primary aim of the study is to evaluate if RPL554 has an additive bronchodilator effect and is well-tolerated in COPD patients when administered in addition to bronchodilators.
Jan-Anders Karlsson, Verona Pharma PLC Chief Executive, said in the press release that the company expects the future findings of these studies will continue to support the results recently announced from a Phase I/IIa study, which showed 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 [medicine] formulation.” He added that Verona expects to report headline findings on both studies in the first half of year 2016.
Karlsson concluded that RPL554 has the potential to become an important new therapy alternative for both obstructive pulmonary disease and asthma, as well as in cystic fibrosis, which is still in a pre-clinical phase.
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