Bronchodilation to be assessed in addition to study’s primary aim of safety and tolerability
Both healthy volunteers and COPD patients to be evaluated
New formulation expected to enable delivery of higher dose of drug in shorter time
Results available in second half 2015
12 January 2015, Cardiff – Verona Pharma plc (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces that a first cohort of healthy volunteers have been successfully dosed with a new proprietary, nebulised formulation of RPL554. These volunteers are part of a combined Phase I/II clinical trial profiling this new RPL554 formulation. The trial includes a single ascending dose study in healthy volunteers and 5 days multiple ascending dose study in both healthy volunteers and patients with COPD (chronic obstructive pulmonary disease). The primary objective of the study is to confirm safety, tolerability and bronchodilation with this new formulation. Up to 120 subjects are planned to be recruited to this study and the results are expected to be available in the second half of 2015.
Verona Pharma is initially developing RPL554 as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. Phase II studies to date with the drug, a novel PDE3/4 inhibitor, have been successfully conducted in over 100 subjects. Results collectively show that the drug is a very potent bronchodilator with the ability to illicit a unique anti-inflammatory response. At the doses tested, RPL554 had a benign side effect profile, which compared favourably with existing standard treatments. The original nebulised formulation of the drug used in these initial studies was devised to provide proof-of-concept data, before developing a new formulation suitable for commercial scale-up.
The new proprietary formulation of RPL554 has demonstrated very attractive properties, in addition to being viable for commercial scale-up. In pre-clinical testing, inhalation of this new formulation was better tolerated, producing significantly less irritation than the one used previously. It is expected that this will result in a significantly improved therapeutic index in patients, implying that they should be able to inhale higher doses over a shorter time interval, improving convenience and potentially compliance.
Dr Jan-Anders Karlsson, Chief Executive Officer of Verona Pharma, said:
“We believe that this new proprietary formulation for nebulised RPL554 will allow us to develop optimally and commercialise this unique drug as an effective treatment for acute exacerbations in COPD. We look forward to reporting the results from this important clinical study, which profiles the new formulation in healthy volunteers and COPD patients, in the second half of 2015.”
The study is being performed at the Medicines Evaluation Unit in Manchester (at the same site as the previous RPL554 study) by lead investigator Professor Dave Singh, with oversight from the Company’s newly appointed Chief Medical Officer, Ken Newman, who is based in Verona Pharma’s subsidiary in the US.
-Ends-
For further information please contact:
Verona Pharma plc Tel: +44 (0) 20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer
N+1 Singer Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
FTI Consulting Tel: +44 (0)20 3727 1000
Julia Phillips / Simon Conway
Notes to Editors
About Verona Pharma plc
Verona Pharma plc is a UK-based clinical stage biopharmaceutical company focused on the development of innovative prescription medicines to treat respiratory diseases with significant unmet medical needs, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis.
Verona Pharma’s lead drug, RPL554, is a first-in-class drug currently in Phase II trials as a nebulised treatment for acute exacerbations of COPD in the hospital setting. The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and therefore has both bronchodilator and anti-inflammatory effects, which are essential to the improvement of patients with COPD and asthma.
Verona Pharma is also building a broader portfolio of RPL554-containing products to maximise its benefit to patients and its value. This includes the very significant markets for COPD and asthma maintenance therapy. The Company is also exploring the potential of the drug in different diseases, such as cystic fibrosis, where it is in pre-clinical testing and has recently received a Venture and Innovation Award from the Cystic Fibrosis Trust.
About The Medicines Evaluation Unit
The Medicines Evaluation Unit (“MEU”) 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 and holds MHRA Phase I accreditation.
About Chronic Obstructive Pulmonary Disease (COPD)
Sixty-five million people worldwide suffer from moderate to severe COPD and the World Health Organisation (WHO) expects COPD to be the 3rd leading cause of death globally by 2020. It is the only major chronic disease with increasing mortality. Currently available drugs are aimed at long-term maintenance therapy, with the market dominated by large pharma. Despite the wide availability of these therapies, COPD patients suffer acute periods of worsening symptoms (exacerbations), which cause, in the US alone, some 1.5 million A&E visits, 726,000 hospitalisations and 120,000 deaths per annum.
IMS Consulting Group considers bronchodilating therapy to be the standard of care, and agents can be administered via handheld devices such as metered dose inhaler (MDI), dry powder inhaler (DPI) and by nebulisers. The nebulised bronchodilator market was worth about $1 billion in 2014 in the US. RPL554 is being developed by Verona Pharma as an add-on therapy to the “Standard of Care” with the objectives of providing rapid and pronounced improvement in lung function, reduced symptoms and both shortened duration of hospital stays and reduced re-admission rates 30 days after discharge from hospital. Studies to date on RPL554 have demonstrated that it has a strongly differentiated 3-way mode of action, being: (1) bronchodilation (the relaxation of smooth muscle in the airway); (2) anti-inflammatory effects on cells and (3) ion channel activation in epithelial cells, with increased mucociliary clearance of the airway.
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