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 |
|
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N+1 Singer |
Tel: +44 (0)20 7496 3000 |
Aubrey Powell / Jen Boorer |
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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.