VRP.L Regulatory News (VRP)

10 Nov 2011 07:00

Verona Pharma plc ("Verona" or the "Company") Phase IIa RPL554 study reports positively for safety and bronchodilation in patients with mild to moderate COPD Successful pilot study to drive future COPD trials; licensing talks ongoing

10 November 2011 - London, UK - Verona Pharma plc (AIM: VRP.L), the biotechnology company dedicated to discovering new drugs for the treatment of chronic respiratory diseases, 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.

Referring to the pilot trial, Professor Cazzola commented, "The extent of bronchodilation, plus the absence of any side effects with RPL544, are very encouraging and show that the drug has potential to be a significant new class of bronchodilators for the treatment of COPD. Many existing bronchodilator drug treatments for COPD produce side effects due to the cardiovascular and other health issues relating to the disease."

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.

Michael Walker, CEO of Verona Pharma, said: "Completion of this trial concludes a busy year for the Company in which we have successfully demonstrated the bronchodilator effects of RPL554 in asthma, and now COPD patients. Both diseases are multi-billion dollar markets that have a need for new drugs.

He added, "While RPL554 has been shown to be a bronchodilator in these diseases, the Company is planning further clinical studies to demonstrate the drug's anti-inflammatory actions. If successful in such trials, RPL554 would be the first drug to have combined bronchodilator and anti-inflammatory actions in a single molecule and is expected to offer clinical advantages over currently available drug treatments. The Company is delighted with the positive clinical results achieved with RPL554 to date and we look forward to reporting further progress in the development and licensing efforts for the drug."

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. The Board is pleased to report that discussions with respect to licencing of RPL554 are ongoing and that a further announcement will be made when appropriate, however this is not expected imminently.

-Ends- Notes to EditorsAbout Verona Pharma plc

Verona Pharma plc is a biotechnology company dedicated to discovering new drugs for the treatment of chronic respiratory diseases, such as COPD, asthma, allergic rhinitis (hay fever) and cough. The Company has three drug projects under development, all aimed at the respiratory and inflammatory disease markets: RPL554, Verona's lead product is in Phase II; VRP700, a novel treatment for chronic cough is also in Phase II; and novel anti-inflammatory polysaccharides (NAIPs) are in the preclinical phase for the treatment of a wide range of respiratory and inflammatory diseases.

About RPL554

RPL554, Verona Pharma's leading drug project, is a long acting bronchodilator and anti-inflammatory drug that is in a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. It is intended for use in the treatment of chronic obstructive pulmonary disease (COPD), asthma and allergic rhinitis (hay fever). The Company is carrying out Phase II clinical trials of the drug in patients with COPD and asthma while simultaneously following-up all potential licensees or partners through which it will take the drug to Phase III clinical development and subsequent commercialisation.

About chronic obstructive pulmonary disease (COPD)

COPD is predominantly characterized by chronic bronchitis and emphysema. It is a progressive degenerative lung disease that results in reductions in lung airflow, making it difficult to breathe. COPD is estimated to affect 210 million people worldwide and is projected to be the third leading cause of death by 2020. The economic burden of COPD in the UK is estimated to be £1.2 billion in health costs and lost productivity.

About The University of Rome Tor Vergata

The University of Rome Tor Vergata, based in south-east Rome, is committed to excellence in teaching and research, as witnessed by the research awards, the numbers of active research contracts, the significant financial support and the economic, social and cultural benefits delivered by its research and teaching activities. Besides teaching and research, the University campus hosts one of the most modern University Hospitals in Italy, the Tor Vergata Polyclinic.

For more information please contact:

Verona Pharma plc Tel: 020 7863 3300 Clive Page, Chairman info@veronapharma.com Michael Walker, CEO WH Ireland Group Plc Tel: 020 7220 1650 Chris Fielding / Jessica Metcalf Chris.fielding@WH-Ireland.Co.UK College Hill Tel: 020 7457 2020 Melanie Toyne Sewell / Gemma Howe verona@thecollegegroup.com