Verona Pharma PLC RPL554 Phase 2a trial started
June 11 2015 - 2:00AM
UK Regulatory
TIDMVRP
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
END
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