Verona Pharma PLC First COPD patient dosed with RPL554 (4893X)
February 22 2017 - 2:01AM
UK Regulatory
TIDMVRP
RNS Number : 4893X
Verona Pharma PLC
22 February 2017
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.
Verona Pharma Commences further RPL554 Phase 2a Clinical
Trial
First COPD patient dosed with RPL554 as an add-on therapy to
tiotropium (Spiriva(c))
Top-line data expected in 4Q 2017
22 February 2017, London - Verona Pharma plc (AIM: VRP.L)
(Verona Pharma), a clinical-stage biopharmaceutical company focused
on developing and commercialising innovative therapeutics for the
treatment of respiratory diseases with significant unmet medical
needs, today announced that the first patient has been dosed in its
Phase 2a clinical trial evaluating RPL554 as an add-on therapy to
tiotropium (Spiriva(R)), a commonly used long-acting
bronchodilator, for the treatment of chronic obstructive pulmonary
disease (COPD). Top-line data from the trial is expected in 4Q
2017.
Verona Pharma's product candidate, RPL554, is an inhaled, dual
PDE3/PDE4 inhibitor that acts as both an anti-inflammatory agent
and a bronchodilator in a single compound. Verona Pharma is
currently developing RPL554 for the maintenance treatment of COPD
patients and for the treatment of patients with cystic fibrosis. It
is also developing RPL554 as an add-on therapy to short-acting
bronchodilators and other commonly used therapies for the treatment
of hospitalised patients with acute exacerbations of COPD.
The primary objective of this Phase 2a trial is to evaluate the
improvement in lung function and duration of effect of RPL554 when
administered as an add-on therapy to tiotropium (Spiriva(R)).
Verona Pharma plans to enroll approximately 30 patients with
moderate to severe COPD in this double-blind, placebo-controlled,
three-way crossover trial. This trial will use spirometry, the
measurement of lung function through the volume and/or flow of air
that can be forcibly exhaled, and whole body plethysmography, a
technique to measure lung volume and airway resistance, to compare
RPL554 to placebo when administered with tiotropium (Spiriva(R)).
The trial is being performed at the Medicines Evaluation Unit in
Manchester, UK, by lead investigator, Professor Dave Singh.
In previous clinical trials, RPL554 has been observed to result
in bronchodilatory effects when used alone or in combination with
other COPD bronchodilators. These trials have shown clinically
meaningful and statistically significant improvements in lung
function when RPL554 is added to two commonly used bronchodilators,
as compared to the improvements in lung function when either
bronchodilator is 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 studies, RPL554
has been well tolerated.
"COPD is a chronic and debilitating respiratory disease for
which there is no cure," said Dr Jan-Anders Karlsson, Verona
Pharma's Chief Executive Officer. "According to the World Health
Organization, COPD is the third leading cause of death globally,
with 210 million people worldwide suffering from the disease. The
clinical data we have announced to date supports our belief that
RPL554 has the potential to be an important new treatment for COPD
patients and we now continue to characterise RPL554 by studying it
as an add-on therapy to tiotropium, a commonly used long-acting
bronchodilator in COPD patients."
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. In clinical trials, treatment with 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.
Verona Pharma is developing RPL554 for the treatment of chronic
obstructive pulmonary disease (COPD), cystic fibrosis, and
potentially asthma.
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 timing of data
releases for our Phase 2a clinical trial of RPL554 as an add-on
therapy to tiotropium (Spiriva(R)).
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.
-Ends-
For further information please contact:
Verona Pharma plc Tel: +44 (0)20 3283
4200
Jan-Anders Karlsson, Chief info@veronapharma.com
Executive 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
This information is provided by RNS
The company news service from the London Stock Exchange
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