TIDMVRP
RNS Number : 4276B
Verona Pharma PLC
04 April 2017
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.
Verona Pharma Doses First Patient in Phase 2a Clinical Trial
Evaluating RPL554 for Cystic Fibrosis
4 April 2017, London- Verona Pharma plc (AIM: VRP.L), a
clinical-stage biopharmaceutical company focused on developing and
commercialising innovative therapeutics for the treatment of
respiratory diseases, announced today that the first patient has
been enrolled and dosed in a Phase 2a clinical study to evaluate
Verona Pharma's product candidate, RPL554, as a treatment for
cystic fibrosis (CF).
The Phase 2a single-dose trial is being conducted in the United
Kingdom. The primary objective of this double-blind,
placebo-controlled study will evaluate the pharmacokinetic and
pharmacodynamics profile and tolerability of RPL554 in up to 10 CF
patients, as well as examine the effect on lung function. Verona
Pharma received its second Venture and Innovation Award from the UK
Cystic Fibrosis Trust in October 2016 to fund this clinical trial.
Verona Pharma received its first Venture and Innovation Award to
fund exploratory pre-clinical studies of RPL554 for the treatment
of CF in 2014.
The trial is being performed at the Cambridge Centre for Medical
Research at Papworth Hospital, Cambridge, UK, one of the largest
specialist cardiothoracic hospitals in Europe, by lead investigator
Professor Andres Floto.
RPL554 is a first-in-class, inhaled, dual inhibitor of the
enzymes phosphodiesterase 3 and 4 (PDE3/PDE4) with
anti-inflammatory as well as bronchodilatory properties, currently
in development for the treatment of chronic obstructive pulmonary
disease (COPD) and CF.
In pre-clinical studies, RPL554 has been observed to stimulate
the CF transmembrane conductance regulator, a protein whose
mutation results in dysfunctional ion channels in epithelial cells,
leading to CF. Based on available data, RPL554 has the potential to
enhance mucociliary clearance (reduce phlegm in the airways),
reduce airway obstruction and inhibit inflammation.
In previous clinical trials in patients with COPD, RPL554 has
been observed to result in statistically significant improvements
in lung function as compared to placebo and has shown clinically
meaningful and statistically significant improvements in lung
function when added to two commonly used bronchodilators as
compared to either bronchodilator administered as a single agent.
RPL554 has also shown anti-inflammatory effects in a standard
challenge study with COPD-like inflammation in human subjects. In
these previous studies, RPL554 has been well tolerated.
"Cystic fibrosis is the most common fatal inherited disease in
the United States and Europe. More than 30,000 people in the U.S.
and more than 70,000 people worldwide are living with cystic
fibrosis," stated Jan-Anders Karlsson, PhD, CEO of Verona
Pharma.
"Two recently approved therapies are indicated only for a subset
of CF patients, and there is a need for novel, effective
anti-inflammatory medications to treat the underlying inflammation
in cystic fibrosis. RPL554 has a differentiated mechanism of action
and pre-clinical data in cystic fibrosis combined with our positive
clinical data in COPD leads us to believe it has the potential to
be an important new treatment for this debilitating condition. We
look forward to progressing the drug through this study and expect
to announce top-line data in the first half of 2018."
Paula Sommer, Head of Research of the UK Cystic Fibrosis Trust,
said: "The Venture Innovation Awards are designed to ensure that
the Trust's funds go as far as possible to supporting
ground-breaking treatments and innovative research by bringing in
vital external funding. The RPL554 trial has the potential to make
a difference to the lives of people with CF, and we are thrilled
that the drug is moving into this important trial stage."
For further information, please contact:
Verona Pharma plc Tel: +44 (0)20 3283
4200
Jan-Anders Karlsson, Chief Executive info@veronapharma.com
Officer
N+1 Singer (Nominated Adviser Tel: +44 (0)20 7496
and UK Broker) 3000
Aubrey Powell / James White
FTI Consulting (UK Media and Tel: +44 (0)20 3727
Investor enquiries) 1000
Simon Conway / Stephanie Cuthbert veronapharma@fticonsulting.com
/
Natalie Garland-Collins
ICR, Inc. (US Media and Investor
enquiries)
James Heins Tel: +1 203-682-8251
James.Heins@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company
focused on developing and commercialising innovative therapeutics
for the treatment of respiratory diseases with significant unmet
medical needs.
Verona Pharma's product candidate, RPL554, is a first-in-class,
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4
that acts as both a bronchodilator and an anti--inflammatory agent
in a single compound. Verona Pharma is developing RPL554 for the
treatment of chronic obstructive pulmonary disease (COPD), cystic
fibrosis, and potentially asthma.
About The Cystic Fibrosis Trust
The Cystic Fibrosis Trust is the only UK-wide charity making a
daily difference to the lives of people with cystic fibrosis, and
those who care for them. Since its start in 1964 it has dedicated
itself to promoting excellence in research and clinical care, as
well as providing practical support and advice to people with
cystic fibrosis and their families. The Trust believes that
everyone with cystic fibrosis deserves the best quality of life and
real hope for the future, with access to high quality, specialist
care. To achieve this goal, it funds research to better understand
and treat cystic fibrosis, review standards of cystic fibrosis
care, and provide information and advice to the CF community.
Forward Looking Statements
This press release contains forward-looking statements. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from our
expectations expressed or implied by the forward-looking
statements, including, but not limited to, the number of patients
to be dosed in and endpoints of our Phase 2a clinical trial to
evaluate RPL554 as a treatment for cystic fibrosis, the timing of
top-line data from the Phase 2 clinical trial, and the potential of
RPL554 to treat cystic fibrosis.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
This information is provided by RNS
The company news service from the London Stock Exchange
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