VRP Verona Pharma Plc

 
TIDMVRP 
 
Verona Pharma plc 
 
("Verona Pharma" or the "Company") 
 
    RPL554 MAD study in healthy volunteers confirms excellent tolerability; 
                       dosing of COPD patients commences 
 
    Multiple ascending dose study of RPL554 in healthy volunteers completed 
        successfully; excellent tolerability at all dose levels tested 
 
    Results continue to support twice daily dosing regimen with new RPL554 
                                  formulation 
 
    Up to 30 COPD patients to be treated in multiple ascending dose study; 
                           results expected Q3 2015 
 
8 June 2015, Cardiff - Verona Pharma plc (AIM: VRP.L), the drug development 
company focused on first-in-class medicines to treat respiratory diseases, 
today announces the successful completion of the second phase of a Multiple 
Ascending Dose (MAD) study in which nebulised RPL554, a novel dual PDE3/PDE4 
inhibitor, was administered to healthy subjects for up to five consecutive days 
at doses up to 16x larger than the previously used active dose. RPL554 is 
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 about $1 billion in 2014 in the US1. 
 
The completed MAD study showed that the drug was well tolerated across all dose 
levels and no maximum tolerated dose was reached. As found in the interim 
results from the single ascending dose (SAD) part of this trial, repeat dosing 
with the new formulation resulted in a longer residence time for RPL554 in the 
lung and slower release into the blood stream, suggesting that twice daily 
dosing may be appropriate. 
 
The Company also announces the commencement of a multiple ascending dose study 
in up to 30 moderate chronic obstructive pulmonary disease (COPD) patients, 
where each dose will be given  for five consecutive days. The primary objective 
here is to further confirm the safety and tolerability seen in earlier parts of 
the trial, as well as to investigate bronchodilation in these COPD patients. 
This study is the final part of a Phase I/II clinical trial with RPL554, using 
a new proprietary nebulised formulation. 
 
The dose range, for both MAD studies, is based on the successfully completed 
SAD part of this trial in which nebulised RPL554 was delivered at doses up to 
16x that previously shown to produce bronchodilation.  As noted in Verona 
Pharma's press release on 23 March 2015, RPL554, in this study in 50 healthy 
volunteers, was well-tolerated and was without effect on cardio-vascular 
parameters and without nausea or vomiting at any dose. 
 
The trial is being performed at the Medicines Evaluation Unit in Manchester by 
lead investigator Professor Dave Singh. 
 
Dr Jan-Anders Karlsson, Chief Executive Officer of Verona Pharma, said: 
 
"This proof of concept trial with our new proprietary formulation for nebulised 
RPL554 continues to generate very encouraging results.  The drug appears to be 
very well tolerated on both single and multiple dosing even at significantly 
elevated levels compared to previous doses tested.  The final phase of this 
trial will be conducted in COPD patients and will examine both the safety and 
bronchodilator response at higher doses.  We have already demonstrated in 
previous trials at lower doses using an earlier formulation that RPL554 is a 
potent bronchodilator with broad anti-inflammatory activity in a single 
molecule.  Accordingly we eagerly await the results from the final part of this 
study, expected in Q3 2015. 
 
"We are initially developing nebulised RPL554 as a treatment for acute 
exacerbations in COPD, where we believe it has significant market potential. 
 We continue to believe that the emerging profile of RPL554 suggests that it 
could potentially become an important addition to available treatment options 
both as a monotherapy and, as a result of its unique mechanism of action, as a 
combination partner for existing drugs for COPD." 
 
Phase I and Phase II studies with RPL554 in its previous nebulised formulation 
were successfully conducted in over 100 subjects.2 Results collectively showed 
that the drug is a very potent bronchodilator with the ability to elicit a 
unique anti-inflammatory response. In these initial studies, patients treated 
with RPL554 had an adverse event profile which was similar to that in patients 
treated with placebo. The original nebulised formulation of the drug used in 
these studies was devised to provide proof-of-concept data, before developing 
the new formulation suitable for commercial scale-up. 
 
It is expected that the new formulation of RPL554 will result in a 
significantly improved therapeutic index in COPD patients, implying that they 
should be able to inhale higher doses with prolonged effect, than the previous 
prototype formulation, offering potential for improvements in convenience and 
compliance, as well as health economic benefit.  In addition, the commercial 
viability of the new formulation is underlined by significantly improved 
stability compared to the previous formulation. RPL554 also has potential as a 
novel therapy in patients with asthma and cystic fibrosis. 
 
                                     -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. 
 
1 IMS Consulting Group market research 2014 
 
2 Franciosi, L.G., et al., Efficacy and safety of RPL554, a dual PDE3 and PDE4 
inhibitor, in healthy volunteers and in patients with asthma or chronic 
obstructive pulmonary disease: findings from four clinical trials. Lancet 
Respir Med, 2013. 1(9): p. 714-27. 
 
 
 
END 
 

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