Verona has announced the start of a Phase II clinical trial to evaluate the pharmacokinetic profile, efficacy and safety of a dry powder inhaler (DPI) formulation of RPL554, for use in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
COPD is a progressive and life-threatening respiratory disease for which there is no cure.
RPL554 is a bronchodilator with anti-inflammatory properties, currently in development for the maintenance treatment of COPD, cystic fibrosis and asthma.
The two-part study with the new DPI formulation is being conducted at a site in the US, and will consist of approximately 36 patients with COPD.
The aim of the first part of the study is to evaluate the pharmacokinetic profile - the study of the time course of drug absorption, distribution, metabolism, and excretion - following a single dose of RPL554 when administered by DPI; data from this part of the study is expected during the first half of 2019.
“Positive results using inhaler formulations could dramatically expand the clinical utility and commercial opportunity for RPL554 in the maintenance treatment of COPD and potentially broaden its use for other respiratory indications, such as asthma,” said Jan-Anders Karlsson, chief executive of the firm, highlighting its potential.
“With an estimated 5.4 million people using inhalers for the maintenance treatment of COPD in the US alone, and another one million patients using nebulised formulations, we believe it is important to understand how RPL554 works via these different delivery platforms in order to fully realise and leverage its clinical potential for patients with respiratory diseases.
"We look forward to building upon the positive results that have been garnered to date utilising the nebulised formulation of RPL554.”