Verona Pharma, a clinical-stage biopharmaceutical company, has received regulatory approval in five European countries (United Kingdom, Germany, Romania, Bulgaria, and the Czech Republic) for a Phase 2b dose-ranging trial of RPL554 for maintenance treatment of COPD. The trial is expected to commence in the third quarter of 2017, with top-line data expected in the second half of 2018.
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the treatment of COPD and cystic fibrosis.
This double-blind, placebo-controlled, parallel group, four-week trial will investigate the efficacy, safety, and dose-response of nebulized RPL554 for the maintenance treatment of COPD across approximately 400 people with the disease in the above named countries. The primary endpoint is evaluating improvement in lung function with RPL554 compared with placebo, as measured by FEV1, a standard measure of exhaled breath volume used to evaluate respiratory function.
“This dose escalation trial directly supports our ongoing development plans for RPL554 and we look forward to enrolling patients in these, and potentially additional countries, subject to further approvals,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “This four-week, 400-patient study is an important step forward in evaluating the potential of RPL554 as a promising first-in-class treatment option for the 210 million people around the world who suffer from COPD on an ongoing basis.”
This clinical trial is part of Verona Pharma’s global strategic services agreement with QuintilesIMS to provide core clinical trial services for RPL554 clinical development programs, as well as provide additional insights to inform development and commercial strategy.