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20 May 2009 07:00
20 May 2009 Verona Pharma plc ("Verona Pharma" or the "Company")
First two stages of RPL554 Phase I/IIa Clinical Trial Yields Positive Results Approval to proceed to final stage of trial
Verona Pharma, the AIM-quoted drug discovery company, is pleased to announce that its asthma and allergic rhinitis (hay fever) treatment, RPL554, has successfully completed the first two stages of its Phase I/IIa clinical trial and received approval to proceed to the final stage of the trial. RPL554 is a novel inhaled treatment for asthma and hay fever that does not involve traditional steroids or beta agonists, and therefore does not have the side effects associated with these treatments.
HIGHLIGHTS
* Approval to proceed RPL554 to the final stage of its Phase I/IIa clinical trial * Strengthening Verona Pharma's portfolio of drugs * Well-positioned to enter licensing should RPL554 successfully complete the final stage of the Phase I/IIa trial
The trial results for RPL554 at stages 1 and 2 of its three stage Phase I/IIa clinical trial were such that the Ethics Committee overseeing the Centre for Human Drug Research in Leiden, the Netherlands, where the trial is being carried out, has given approval for the trial to proceed to the final stage.
Stage 1 of the clinical trial tested the drug's safety in healthy volunteers. The second stage was an adaptive trial designed to explore whether the drug has beneficial effects, in terms of bronchodilation and bronchoprotection in asthmatics, while allowing further safety testing and selection of an appropriate dose for the final trial stage.
RPL554 is now entering stage 3 of the clinical trial which is expected to be completed in Q3 of 2009.
The third and final stage of the trial is designed as a randomised, double-blinded placebo-controlled crossover trial in a group of 10 allergic asthmatic and 10 allergic rhinitis patients. This will test whether the drug, at the dose selected on the basis of the stage 2 results, has both bronchodilator and bronchoprotective effects within the lung airways of asthmatics, as well as anti-inflammatory actions within the nasal airways of allergic rhinitics.
Verona Pharma retains a strong balance sheet and cash position after funding the cost of this trial. Furthermore, Verona Pharma's management and development teams have a wealth of experience in the pharmaceutical industry as well as a portfolio of novel drug treatments alongside RPL554.
Chief Executive Dr. Michael Walker said:
"We are delighted with the results of stages 1 and 2 and look forward to moving the drug into the final stage 3 of our Phase I/IIa clinical trial that is designed to demonstrate both safety and effectiveness in the treatment of asthma and rhinitis.
"It has always been our strategy to develop our compounds to a stage where pharmaceutical companies can see proven potential as drugs before entering into a partnership or licensing them to a third party. With RPL554 entering the final stage of its pivotal Phase I/IIa trial, we will actively pursue the possibilities for potential licensing agreements or partnerships to commercialise RPL554.
"We believe that the Company is currently in a very strong position, with RPL554 reaching the final stage of its clinical trial and two further projects in the pipeline. A number of large international pharmaceutical companies' patents are due to expire over the next 12 months leaving them open to the possibility of the market being flooded with cheaper generic equivalents. This in turn offers Verona Pharma substantial potential opportunities for our new unique patented treatments."
--END-- For more information please contact:
Professor Clive Page 07971 504 931 Chairman, Verona Pharma plc Adrian Kirk 0161 832 2174 WH Ireland Ltd Nick Rome / Robyn Samuelson 020 7920 3150 BishopsgateCommunications
About Verona Pharma plc (www.veronapharma.com)
Verona Pharma plc (AIM:VRP) is an AIM-quoted life sciences company dedicated to the research, discovery and development of 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.
The Company currently has three potential drug treatments under development and continues to look for other possible drug development opportunities aimed at the respiratory and inflammatory diseases markets.
Globally, treatment of these diseases cost an estimated US$20 billion per annum. Despite such diseases being among the most prevalent diseases in the industrialised world, many of the current treatments have unwanted side effects, and/or limited effectiveness.
Verona Pharma was admitted to AIM in September 2006, and is run by two 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 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 (www.chdr.nl)
The Centre for Human Drug Research is a Netherlands based, 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.
www.veronapharma.com Ticker symbol: VRP
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