14 Oct 2015 07:00
VERONA PHARMA PLC - Start of RPL554 Phase IIa combination studyVERONA PHARMA PLC - Start of RPL554 Phase IIa combination study
PR Newswire
London, October 13
Verona Pharma plc("Verona Pharma" or the "Company")
Verona Pharma announces start of RPL554 Phase IIa combination study
First COPD patients dosed with RPL554 on top of salbutamol and ipratropiumHeadline data expected Q2 2016
14 October 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 the first patients have been dosed in a Phase IIa combination study to evaluate the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disease (COPD). RPL554 is a novel inhaled PDE3/PDE4 inhibitor with anti-inflammatory as well as bronchodilatory properties, currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. The nebulised bronchodilator market was worth approximately $1 billion in 2014 in the US.1
The primary objective of this study is to evaluate whether RPL554 has an additive bronchodilator effect in COPD patients, when administered in addition to standard of care bronchodilators. Up to 30 patients will be enrolled in this double-blind, placebo-controlled, six way crossover study, which will investigate the pharmacodynamic effect of nebulised RPL554 in a commercially scalable suspension formulation. This trial will use spirometry2 and whole body plethysmography3 to compare RPL554 to placebo, when administered with a beta2 agonist (salbutamol), and with a muscarinic antagonist (ipratropium). The trial is being performed at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh.
As reported on 29 September 2015, Phase IIa results from a prior study using nebulised RPL554 alone in stable COPD patients with moderate severity of disease, showed that, in addition to good tolerability and safety profile, RPL554 caused a pronounced improvement in lung function, as measured by peak FEV1, suggesting the drug produced a clinically meaningful bronchodilator effect.
Dr Jan-Anders Karlsson, the CEO of Verona Pharma, said:
“We believe RPL554 has the potential to become an important new treatment option for COPD patients. This latest study will evaluate the potential of RPL554 when added to existing therapies. We recently announced encouraging results from our standalone Phase IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 is well tolerated and has allowed us to extend the dose range and the duration of bronchodilation effect that can be produced in COPD patients. Headline data from this combination study is expected in Q2 2016.
“We are also evaluating the potential of RPL554 in a Phase IIa trial in asthma patients and look forward to reporting headline data in Q1 next year.”
-Ends-
1 IMS Consulting Group market research 2014
2 Spirometry is the measurement of lung function through the volume and /or flow of air that can be forcibly exhaled
3 Whole body plethysmography is a technique to measure lung volume and airway resistance
For further information please contact:
| Verona Pharma plc | Tel: +44 (0)20 7863 3300 |
| Jan-Anders Karlsson, CEO | |
| N+1 Singer | Tel: +44 (0)20 7496 3000 |
| Aubrey Powell / Jen Boorer | |
| FTI Consulting | Tel: +44 (0)20 3727 1000 |
| Simon Conway / Stephanie Cuthbert / Natalie Garland-Collins |
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 IIa 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 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 third 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.