Bronchodilation in asthmatics maintained with daily dosing of RPL554
• Identical bronchodilator responses seen after 1, 3 and 6 days of treatment
• No evidence of RPL554 accumulation in plasma over 6 days
• There were no safety concerns although there was a minor increase in heart rate at day 6 only
• Results provide a basis for future long term trials, especially for establishing anti-inflammatory actions
17 August 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 completed a further Phase II study to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma.
The trial, which took place at the Centre for Human Drug Research (CHDR) at Leiden, The Netherlands, treated 12 patients with mild asthma with daily doses of RPL554 for a period of 6 days. The patients were tested every day but the major observations on bronchodilation were on days 1, 3 and 6 when measurements were continued for 6 hours. The assessment of bronchodilation was based on FEV1 (forced expiratory volume at 1 second), a common method used to evaluate the bronchodilator effects of drugs. The trial was a single blind, randomised, placebo-controlled trial.
The trial successfully demonstrated that RPL554 had sustained bronchodilator actions throughout the treatment period. There was no accumulation of the drug in plasma and no safety issues were observed. There was a minor increase in heart rate at day 6 only, being the last day of treatment.
This is the third trial with RPL554 in patients with allergic asthma. The second trial, recently completed at the CHDR in February 2011, established the effectiveness of higher doses of the drug. A further trial currently being planned to test the anti-inflammatory actions of RPL554 is expected to start later this year.
Michael Walker, CEO of Verona Pharma, said: "The clinical studies performed so far with RPL554 have defined the actions of our drug in terms of doses that are safe and produce a clear and unequivocal bronchodilator effect. This bronchodilator effect is of value in the treatment of asthma, and possibly chronic obstructive pulmonary disease (COPD). The sustained bronchodilator effect of RPL554 throughout the treatment period is an important finding, and one that we will use when selecting the dosing regimen for a further trial we are currently planning to demonstrate unequivocally the anti-inflammatory actions of RPL554.”
During this time when licensing efforts continue with RPL554 the Company is conducting further clinical trials to broaden its knowledge of the therapeutic usefulness of RPL554 in asthma and COPD and thereby add value to the overall RPL554 licensing package. If the proposed anti-inflammatory trial is successful, RPL554 will have a therapeutic profile as the first of a new class of drugs for the treatment of both asthma and COPD; common diseases with significant markets that are in need of new drugs.
Notes to Editors
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 asthma, allergic rhinitis (hay fever), chronic
obstructive pulmonary disease (COPD) and cough. The Company has
three potential drug treatments under development aimed at the
respiratory and inflammatory diseases markets: RPL554,
Verona’s lead product in Phase II; VRP700, a novel treatment
for chronic cough currently in a clinical trial at the University
of Florence; and novel anti-inflammatory polysaccharides (NAIPs) in
research phase for the treatment of a wide range of respiratory and
RPL554 is Verona Pharma's lead drug compound which is a long acting bronchodilator/anti-inflammatory drug (belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor) for the treatment of allergic rhinitis (hay fever) and potentially asthma. In September 2009, the Company completed a Phase I/IIa clinical trial of the drug which showed clear clinical benefits in patients with asthma and allergic rhinitis. The Company is carrying out further clinical trials of the drug to provide additional clinical data and to take the drug through to the next development stage. The Company is simultaneously seeking licensing agreements or partnerships for the further development and commercialisation of the drug.
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.
For more information please contact:
Verona Pharma plc
Clive Page, Chairman Tel: 020 7863 3300
Michael Walker, CEO
Evolution Securities Limited
(NOMAD and Joint Broker) Tel: 020 7071 4300
Bobbie Hilliam / Tim Redfern / Patrick Castle
WH Ireland Group Plc (Joint Broker)
Richard Smith / Nicola Rayner Tel: 0121 265 6300
Melanie Toyne Sewell / Gemma Howe Tel: 020 7457 2020
Posted: August 2011