RPL554 is a first-in-class dual inhibitor of the enzymes phosphodiesterase 3 and 4. The drug has anti-inflammatory and bronchodilator properties. An inhaled formulation of the drug therapy candidate is in development for the treatment of COPD, cystic fibrosis, and potentially asthma.
In previous studies in patients with COPD, RPL554 was shown to lead to statistically significant improvements in lung function. In addition, clinically meaningful and statistically significant improvements were sustained when administered together with two commonly used bronchodilators, compared to treatment with either bronchodilator on its own, the company said in a press release.
After receiving a green light to enroll patients in five European countries — the United Kingdom, Germany, Romania, Bulgaria, and the Czech Republic — the trial has now begun dosing patients in multiple centers.
About 400 patients are expected to be enrolled in the European trial to investigate the effectiveness, safety and dose-response of nebulized RPL554 for four weeks.
The trial’s primary goal is an improvement in lung function with RPL554 compared to placebo, as measured by forced expiratory volume in one second (FEV1) — a measurement of exhaled breath volume used to evaluate respiratory function.
Top-line results of the trial are expected in the second half of 2018.
“Dosing our first patients in this larger four-week Phase 2b trial is an important step forward in the evaluation of nebulized RPL554 as a novel therapy for COPD patients with significant unmet medical needs,” said Jan-Anders Karlsson, PhD, and CEO of Verona.
“The clinical data generated to date and the mechanism of action of RPL554 makes it a promising first-in-class treatment option. We look forward to working with patients and healthcare providers across the trial sites to gather meaningful data and insights …” Karlsson added.
Moreover, as part of a global strategic services agreement with QuintilesIMS, Verona announced in June that a clinical trial would begin to evaluate RPL554 in COPD and cystic fibrosis patients in the United States. The announcement was made following the investigational new drug status given to RPL554 by the U.S. Food and Drug Administration. Initial results of the trial are expected later this year.