Verona Pharma plc, a United Kingdom-based biopharmaceutical company dedicated to therapies for respiratory disorders, recently announced the completion of the patient enrollment phase in two Phase 2a clinical trials assessing the company’s product RPL554.
RPL554 is a “first-in-class” inhaled drug under development for respiratory conditions such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, and asthma. RPL554 is an inhibitor of two enzymes, called phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), which are involved in the development and disease progression of immunological respiratory disorders. The drug can act both as an anti-inflammatory and a bronchodilator, differentiating it from other existing therapeutic agents.
RPL554 is under development as a nebulized therapy for acute exacerbations in patients with COPD, either in a hospital setting or at home-care. It was previously reported that RPL554 alone is well-tolerated by patients with moderate COPD, having a good safety profile. Importantly, RPL554 was found to be able to improve the patient’s lung function through a significant bronchodilation effect.
Verona Pharma is currently conducting two Phase 2a studies on RPL554. One is a dose-finding trial in 29 asthma patients, and the other is to evaluate the combination of RPL554 with standard of care bronchodilators in COPD patients. Results from both trials are expected in 2016.
“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,” said the CEO of Verona Pharma, Dr. Jan-Anders Karlsson, in a company press release.
The Phase 2a study combining RPL554 and standard of care bronchodilators [namely a beta 2 agonist (salbutamol) and a muscarinic antagonist (ipratropium)] as a therapy for COPD patients, is a double-blind, placebo-controlled study that enrolled 30 patients. The trial will assess the clinical impact of nebulized RPL554 in comparison to a placebo treatment, and is being conducted at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh.