Verona Pharma PLC Start of RPL554 Phase IIa combination study

 
TIDMVRP 
 
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 ipratropium 
                        Headline 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. 
 
 
 
END
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