Verona Pharma PLC Patient enrolment completed in RPL554 PhIIa studies

 
TIDMVRP 
 
Verona Pharma plc 
 
("Verona Pharma" or the "Company") 
 
   Completion of patient enrolment in two RPL554 Phase IIa studies, ahead of 
                               expected timeline 
 
                 Headline data expected in Q1 2016 and Q2 2016 
 
5 November 2015, Cardiff - Verona Pharma plc (AIM: VRP.L), the drug development 
company focused on first-in-class medicines to treat respiratory diseases, 
today announces it has completed patient enrolment for the Phase IIa 
dose-finding study of RPL554 in asthma and the Phase IIa combination study of 
RPL554 in chronic obstructive pulmonary disease (COPD), in which the drug is 
being administered in addition to standard of care bronchodilators.  Headline 
data is expected Q1 2016 for the asthma study and Q2 2016 for the COPD 
combination study. 
 
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 
 
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 are very pleased to have completed recruitment in both of these studies 
ahead of our plan. We believe the results will continue to build on the 
positive data recently announced from our  Phase I/IIa study, which 
demonstrated that the new commercially scalable, suspension formulation of 
RPL554 is well tolerated and that the extent of the bronchodilation exceeded 
that seen in earlier studies with the prior formulation.  We believe RPL554 has 
the potential to become an important new treatment option for both COPD and 
asthma patients and look forward to reporting headline data from both studies 
in the first half of next year." 
 
About the studies 
 
Phase IIa study of RPL554 asthma patients 
 
In this study 29 patients with mild to moderate persistent asthma will each 
receive single doses of nebulised RPL554, from the very low dose to the highest 
dose previously tested in the Phase Ib single ascending and multiple ascending 
dose (SAD and MAD) studies of the same drug in healthy subjects.  In this 
double-blind, placebo-controlled, crossover study, each patient will also 
receive two different doses of nebulised salbutamol, a commonly used 
bronchodilator in these patients, and placebo.  The primary objective of the 
trial is to establish the dose-dependency of the bronchodilator effect and the 
duration of action of RPL554 in asthma patients.  The study is being performed 
at Celerion (Belfast, Ireland) and Skane University Hospital (Lund, Sweden). 
 
Phase IIa combination study of RPL554 in COPD patients 
 
The primary objective of this study is to evaluate whether RPL554 has an 
additive bronchodilator effect and is well tolerated in COPD patients, when 
administered in addition to standard of care bronchodilators. Thirty patients 
have been 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. 
 
                                    -Ends- 
 
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 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. 
 
References 
 
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 
 
 
 
END
(END) Dow Jones Newswires
November 05, 2015 02:00 ET (07:00 GMT)
Verona Pharma (LSE:VRP)
Historical Stock Chart
From Jun 2024 to Jul 2024