VRP Verona Pharma Plc

 
TIDMVRP 
 
Verona Pharma plc 
 
                      ("Verona Pharma" or the "Company") 
 
    First patientssuccessfully dosed in clinical trial withnew commercially 
                    scalable formulation ofnebulised RPL554 
 
Bronchodilation to be assessed in addition to study's primary aim of safety and 
                                 tolerability 
 
            Bothhealthy volunteers and COPD patientsto be evaluated 
 
 New formulation expected to enable delivery of higher dose of drug in shorter 
                                     time 
 
                     Results availablein 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 Officerof Verona Pharma,said: 
 
"We believe that thisnew 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, whichprofiles 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. 
 
 
 
END 
 

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