11th Sep 2009 07:00
11 September 2009 Verona Pharma plc ("Verona Pharma" or the "Company") A single dose of RPL554 is safe and effective in patients with asthma
Verona Pharma plc, the AIM-quoted drug discovery company, announces the final results of its clinical Phase I/IIa trial recently completed at the Centre for Human Drug Research, Leiden, The Netherlands. The study was designed to ascertain whether a safe dose of RPL554, given by inhalation to a group of clinically stable mildly asthmatic patients that were not on maintenance anti-asthma therapy, produced bronchodilation (relaxation of airways) as well as bronchoprotection (protection against the airway stimulant methacholine). In a separate group of asymptomatic patients with allergic rhinitis who were not on maintenance therapy, the effects of RPL554 on the inflammatory cellular responses to a nasal allergen challenge were tested.
HIGHLIGHTS
* RPL554 shows clear clinical benefits in proof of concept trial in patients with asthma and allergic rhinitis while showing a good safety profile * Trial demonstrates that RPL554 has beneficial actions in asthmatics, and potentially in patients with allergic rhinitics * Verona Pharma now plans to partner or license RPL554 * Two further projects in pipeline
The dose of RPL554 chosen for the study produced no adverse effects in healthy subjects or in asthmatic or rhinitic patients with respect to their cardiovascular, gastrointestinal or respiratory status, neither did it change laboratory measures of safety.
RPL554 induced a marked statistically and clinically significant bronchodilation in the asthmatics that was still detectable at least seven hours after dosing. The drug also induced a statistically and clinically significant bronchoprotection against methacholine challenge.
In the allergic rhinitic group, the same single dose of RPL554 reduced the percentage of inflammatory cells (eosinophils and neutrophils) obtained from the nose 7 and 24 hours after allergen challenge. The numbers of inflammatory cells were reduced by RPL554. While not statistically significant, the reduction was considered of clinical significance.
The Company is very satisfied by all the results since they clearly indicate that a safe dose of RPL554 has beneficial actions in asthmatics, and possibly in patients with allergic rhinitics, despite being given only once by inhalation.
Within the context of drugs that produce related therapeutic effects, Professor Mario Cazzola, Professor of Respiratory Medicine, University of Rome, Tor Vergata, Rome, commented:
"Verona Pharma, using an innovative clinical trial with only 44 subjects, has succeeded in demonstrating that their compound RPL554 can potentially provide, in a single drug as opposed to a combination of drugs, a new treatment for asthma, rhinitis and possibly chronic obstructive respiratory disease. I look forward to further clinical trials with this drug to fully define its therapeutic value which I suspect could be very significant."
Chief Executive Dr. Michael Walker said:
"We are delighted to announce that RPL554 has shown clear clinical benefits in a proof of concept trial in patients with asthma and allergic rhinitics.
"Verona Pharma's strategy is to develop potential new drugs to a clinical proof of concept stage where pharmaceutical companies can see their proven potential before entering into a partnership or licensing relationship. With RPL554 having successfully completed the final stage of its proof of concept Phase I/ IIa trial, we are now actively seeking licensing agreements or partnerships to commercialise RPL554.
"While investigating licensing and partnering possibilities for RPL554, we will continue to advance our other two drug discovery projects that are in the pipeline. The current situation where a number of large international pharmaceutical companies have patents that are due to expire opens a window of opportunity for companies such as Verona Pharma and its drug discovery projects."
--END-- For more information please contact: Professor Clive Page 07971 504 931 Chairman, Verona Pharma plc Barry Saint / Tim Redfern / Esther Lee 020 7071 4300 Evolution Securities Limited Nick Rome / Robyn Samuelson 020 7562 3350 Bishopsgate Communications
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 two other potential drug projects 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. 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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