9 March 2012 - London, UK - Verona Pharma plc (AIM: VRP.L), the biotechnology company focused on chronic respiratory diseases, has signed a contract with the Medicines Evaluation Unit (MEU) in Manchester, UK to undertake a Phase II clinical trial to demonstrate the anti-inflammatory effects of RPL554 with respect to chronic obstructive pulmonary disease (COPD).
The trial, being led by Professor Dave Singh, is designed as a randomized, double-blind, placebo-controlled crossover study in healthy volunteers who will have their airways exposed to an inflammatory stimulus which causes the infiltration of specific cells resulting in inflammation. Patients will then be treated using 6 repeated daily doses of RPL554 via a nebulizer inhaler, with the primary endpoint being the reduction of inflammation. This is a standard clinical test used and recognised by big pharma to evaluate the potential anti-inflammatory effects of a drug in the treatment of COPD.
The trial is planned to start within the next couple of months following necessary ethical and regulatory approvals. The preliminary results from the trial are expected in Q4 this year.
This clinical trial follows earlier work to test the anti-inflammatory actions of RPL554, including preclinical studies and a pilot nasal study in humans performed as part of the initial Phase I/IIa clinical trial with RPL554.
Michael Walker, CEO of Verona Pharma, said: “The fundraising completed in January this year has enabled us to initiate this important trial to show that RPL554 is anti-inflammatory. We have already demonstrated that this drug is a bronchodilator i.e. dilates the airways, enabling patients to breathe more easily. If we can demonstrate there is also a combined anti-inflammatory action, this would place RPL554 in a completely new class of therapy for COPD and asthma sufferers.”
He added: “Our objective continues to be to appoint a partner to develop RPL554 into a marketed medicine. The results from this trial will provide further useful and important data for this purpose”.
About 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.
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, commonly known as smokers’ disease, 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 Medicines Evaluation Unit (MEU)
The Medicines Evaluation Unit (MEU) Ltd is one of the UK’s leading contract research organisations, working in collaboration with the University Hospital of South Manchester. The MEU specialises in performing clinical trials (from Phase I through to IV) in respiratory/inflammatory medicine and related areas. The MEU has an outstanding reputation for performing high quality clinical research complying with UK Clinical Trials Legislation and EU Directives.
For more information please contact:
Verona Pharma plc
Clive Page, Chairman
Michael Walker, CEO
Tel: 020 7863 3300
WH Ireland Group Plc
Tel: 020 7220 1650
Melanie Toyne Sewell
Tel: 020 7457 2020