VRP.L Regulatory News (VRP)

9 Sep 2008 07:00

For release 07.00, 9 September 2008

Verona Pharma Verona Pharma signs to begin human clinical trials for potential anti-asthma drug

The AIM-quoted drug discovery company Verona Pharma plc has signed a contract to begin clinical trials in humans with RPL554, its potential ground-breaking drug for the treatment of asthma and allergic rhinitis (hay fever).

This marks a key milestone in the development of RPL554, which is expected to provide effective treatment for these respiratory diseases but without many of the side effects reported with most current drug treatments.

The trial will be conducted in the Netherlands at the Centre for Human Drug Research (CHDR) on obtaining the necessary ethical and regulatory approvals. Verona Pharma anticipates that the first subjects will receive RPL554 in November 2008 and the trial will be completed during the first half of 2009.

The trial will be a combined Phase I / Phase IIa clinical trial, designed to ascertain the safety of RPL554 and at the same time provide evidence of its clinical effectiveness in asthmatics and patients with allergic rhinitis. Verona Pharma expects the trial to establish RPL554's bronchodilator (opens airways), broncho-protective (protects against irritants that provoke asthma) and anti-inflammatory actions.

Chief Executive Dr Michael Walker said: "RPL554 targets common respiratory diseases that cost globally an estimated US$20 billion to treat. The commencement of this clinical trial will mark a major step in the development process for RPL554, a drug that could provide a significant improvement in the treatment of asthma and allergic rhinitis."

Success in the trial is expected to open up opportunities for partnerships and licensing by which RPL554 could be taken through the necessary further clinical development to commercialisation.

The initiation of the clinical trial follows the successful completion of earlier work in toxicology, safety pharmacology and pharmacology and formulation conducted at various scientific organisations and laboratories in Europe, the UK, Australia and Canada.

Alongside the RPL554 project, Verona Pharma has two on-going early-stage discovery and development programmes, involving work on the potential effectiveness of anti-inflammatory substances found in starfish for the treatment of respiratory diseases, and a treatment for coughing.

-ends-

For more information please contact:

Professor Clive Page,

Chairman, Verona Pharma plc 07971 504 931

David Youngman,

WH Ireland Ltd 0161 832 2174

Clemmie Carr / Andrew Dunn

Tavistock Communications 020 7920 3150

About Verona Pharma plc (www.veronapharma.com )

Verona Pharma plc (AIM:VRP) is an AIM-quoted drug discovery company that is focused on finding new therapeutic drugs for the treatment of allergic rhinitis (hay fever) and other chronic respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD), as well as chronic inflammatory diseases.

Globally, these diseases are costing an estimated US$20 billion per annum to treat, and while they are among the most prevalent diseases in the industrialised world, many of the available treatments have unwanted side effects, and/or limited effectiveness.

Verona Pharma was admitted to AIM in September 2006, and is run by two of the world experts in pharmacology and drug discovery. Dr Michael Walker is Emeritus Professor of Anesthesiology, Pharmacology and Therapeutics at the University of British Columbia, and a founder of other biotech, and biotech related companies. Chairman Dr Clive Page is a Professor of Pharmacology at King's College London, and an internationally-recognised authority in lung diseases and inflammation.

Verona Pharma's compound RPL554 is a long-acting bronchodilator/ anti-inflammatory drug (belonging to a class of drugs known as mixed phosphodiesterase (PDE) 3/4 inhibitors. As a PDE3/4 inhibitor, RPL554 targets the underlying cause of respiratory diseases by dilating the bronchial passages and blocking inflammation through a mechanism that is distinct from the established steroid and beta agonist drug classes.

RPL554 was co-invented by Sir David Jack and Alex Oxford, formerly of GlaxoSmithKline. Sir David was Research Director and the pioneer of many of the leading respiratory drugs currently available. He is regarded as one of the world's most successful inventors of significant new medicines.

Verona Pharma is also seeking to develop an anti-tussive drug that works to suppress the generation of a cough signal at the nerve endings in the lungs. The Company's longer term focus is to develop novel polysaccharides (NAIPS) as potential anti-inflammatory drugs for the treatment of respiratory allergies, asthma and other inflammatory diseases.

About The Centre for Human Drug Research (CHDR) (www.chdr.nl)

The Centre for Human Drug Research (CHDR) is a Dutch, full-service contract research organisation with tight connections to academic hospitals. It provides a full range of high quality clinical pharmacology services to the pharmaceutical industry, working as collaborative partners offering sophisticated advice to clients on all aspects of the process of drug development. It also runs its own research programmes, develops new biomarkers to optimize clinical research, Over the past 20 years this approach has led to a wide diversity of biomarkers that help to perform proof-of-pharmacology and proof-of-concept studies in the earliest phase of the drug development programmes.