Verona Pharma plc
("Verona Pharma" or the "Company")
RPL554 Phase 2a
trial started; headline data expected Q1 2016
First asthma
patients dosed with RPL554 in new proprietary nebulised
formulation
11 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 that the first patients have been dosed with RPL554
in a Phase 2a dose-finding trial in asthma patients using the
Company’s new proprietary nebulised formulation. RPL554 is a
novel inhaled PDE3/PDE4 inhibitor, currently in development as a
nebulised treatment for acute exacerbations in chronic obstructive
pulmonary disorder (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 study is being carried out in asthmatics as typically a dose
response relationship to bronchodilators can be more accurately
established in this group of patients, compared to COPD patients.
In this trial, up to 30 patients with mild to moderate
chronic asthma will each receive single doses of nebulised RPL554,
from the very low dose to the highest dose previously tested in the
Phase 1b 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
bronchodilator effect and duration of action of RPL554 in asthma
patients. The study is being performed at Celerion (Belfast,
Ireland) and Skane University
Hospital (Lund, Sweden).
As reported on 23 March 2015 and
8 June 2015, Phase 1b results in SAD
and MAD studies of nebulised RPL554 with this new formulation in
healthy volunteers, have demonstrated that the drug is well
tolerated in doses up to 16 times larger than those previously
demonstrated to produce bronchodilation using the prior
formulation. Given that this new formulation is better
tolerated and higher doses can be administered, this latest trial
is likely to provide useful data for further development work on
RPL554 and also its potential as a future treatment for asthma
sufferers.
Dr Jan-Anders
Karlsson, the CEO of Verona Pharma, said:
“We have demonstrated in our previous
studies in healthy volunteers with RPL554 in its new formulation
that the drug is well tolerated at significantly higher doses than
have previously been shown to produce bronchodilation. We
have now begun examining the safety and bronchodilator responses to
RPL554 in COPD, in the ongoing Phase 1b study, and in asthma
patients using our new formulation.
Given that constriction of the
airways is a key feature of different lung diseases, including
asthma, a novel drug that produces potent bronchodilation but has a
novel mechanism of action, would also be of potential value in
these patients, especially when presenting with an acute
exacerbation whilst on the maximum tolerated doses of their current
asthma medicine. The data from this latest study should
inform our further development plans for RPL554 when it reports
initial data in Q1 2016.”
-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 |
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 2 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 UK Cystic
Fibrosis Trust.
About Lung and Allergy, Clinical Trial
Unit (CTU), Skane University Hospital, Lund, Sweden
The Lung and Allergy clinical trial unit
(http://www.akcsyd.se/forskning/provningsenheten) has been working
mainly with early phase II and III studies in Asthma and or COPD
for 10 years. The CTU is a part of an academic respiratory research
network group run by Professor Leif
Bjermer a recognised expert in this field. The scientific
work is focused on disease mechanisms in asthma and COPD
identifying and validating potential new treatment targets by means
of invasive and non-invasive techniques, advanced histology, cell
and molecular biology. The CTU is equipped with a complete
respiratory physiology lab with a special focus on techniques that
can address small airway pathology. Biomarkers, biogenetics and
functional imaging is also part of the explorative profile. We also
perform invasive studies with bronchoscopy, biopsies, brushing and
lavage.
About Celerion
Celerion, a leader in early clinical research, delivers Applied
Translational Medicine. Celerion applies expertise and experience
to translating information gained in research discoveries, to
knowledge of drug action and effect in humans to support early drug
development decisions and the clinical pharmacology labeling of new
medicines.
With over 40 years of experience and 600 global clinic beds
(including 24 in-hospital), Celerion conducts and analyses
First-in-Human, clinical Proof-of-Concept, Cardiovascular Safety
Services (TQT, robust QT), ADME and NDA-enabling clinical
pharmacology studies. Celerion provides expertise on modeling and
simulation, study design, medical writing (protocols and reports),
clinical data sciences, biostatistics, and PK/PD analysis as well
as small and large molecule bioanalytical assays through clinical
drug development. Regulatory, drug development and program
management complement Celerion’s service offerings. For more
information please visit http://celerion.com/.
About Asthma
Asthma remains one of the most common chronic diseases in the
world and is characterised by recurrent breathing problems and
symptoms such as breathlessness, wheezing, chest tightness, and
coughing. In the U.S. asthma accounts for approx. 1.9 million
annual emergency room visits and approx. 500,000 annual
hospitalisations.
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.
Bronchodilating therapy is considered 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.1 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 (CFTR)
activation in epithelial cells, and thus the potential to increase
mucociliary clearance in the airway.
References
1 IMS Consulting Group market research 2014