Date: 2011-11-10
Type of information:
phase: 2a
Announcement: results
Company: Verona Pharma (UK)
Product: RPL554
Action
mechanism: RPL554 is a long acting bronchodilator/anti-inflammatory drug belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. Verona Pharma is investigating its use for the treatment of respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis (hay fever).
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country: Italy
Trial
details: This Phase II trial takes place at University of Tor Vergata in Rome. The trial is designed to evaluate the safety and efficacy of RPL554 in patients with mild to moderate forms of COPD. It is being performed as an open label trial to observe the bronchodilator effects of the drug in COPD patients. Such patients often have concomitant cardiovascular disease and are older and thus at a greater risk of potential adverse effects than were the younger asthmatic patients who were studied in the previous two reported trials of RPL554 carried out at the Centre for Human Drug Research (CHDR) in The Netherlands.
The measurements of interest in the trial are the standard measure of FEV1 (Forced Expiratory Volume in 1 sec) to test the effect of RPL554 on lung function, and blood pressure and electrocardiography (ECG) to test the safety of the drug in this patient group. The drug will be given in a nebulized form as was the case in the previous trials.
Latest
news: * On November 10, 2011, Verona Pharma has announced that it has successfully demonstrated in a Phase IIa RPL554 study bronchodilator effects in patients with chronic obstructive pulmonary disease (COPD).
The pilot Phase IIa study was carried out by a world leading expert on COPD, Professor Mario Cazzola at the Tor Vergata Polyclinic, University of Rome. The study involved administering nebulized RPL554 as a single dose of 0.018 mg/kg to patients with COPD. The study met its primary endpoint by showing that the drug produced a significant improvement in lung function of up to a 10% increase in FEV1 (forced expiratory volume at 1 second) as compared with placebo. FEV1 is a standard method used to evaluate the bronchodilator effects of drugs. In addition, the duration of action observed was similar to that previously seen with RPL554 in patients with asthma.
Overall, RPL554 was well tolerated and no cardiovascular or other safety issues were observed, despite COPD being a condition in which concurrent cardiovascular disease is common.
This successful pilot study, which is the first trial with RPL554 in patients with COPD, will be expanded to incorporate more patients so as to provide further safety data for the ongoing development of RPL554 as a treatment for COPD and other respiratory diseases.
With respect to the future development and commercialisation of RPL554, the Board of Verona has stated previously that it is seeking the most compatible and appropriate partner to develop RPL554 into a marketed medicine. This search is worldwide and encompasses all appropriate and suitably sized pharmaceutical companies with expertise with respiratory drugs used in COPD and asthma. Discussions with respect to licencing of RPL554 are ongoing.
