Verona Pharma Receives Regulatory Approval to Commence Phase 2b Clinical Trial of RPL554 for COPD Maintenance Treatment in Fi...
27 June 2017 - 4:00PM
Verona Pharma plc (AIM:VRP) (NASDAQ:VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapies for respiratory diseases,
announces today regulatory approval in five European countries,
comprising the United Kingdom, Germany, Romania, Bulgaria, and the
Czech Republic, for a Phase 2b dose-ranging trial of RPL554 for
maintenance treatment of chronic obstructive pulmonary disease
(COPD). The trial is expected to commence in the third quarter of
2017, with top-line data expected in the second half of 2018.
RPL554 is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have
anti-inflammatory as well as bronchodilator properties, and is
currently in development for the treatment of COPD and cystic
fibrosis.
This double-blind, placebo-controlled, parallel
group, four-week trial will investigate the efficacy, safety, and
dose-response of nebulized RPL554 for the maintenance treatment of
COPD across approximately 400 people with the disease in the above
named countries. The primary endpoint is evaluating improvement in
lung function with RPL554 compared with placebo, as measured by
FEV1, a standard measure of exhaled breath volume used to evaluate
respiratory function.
“This dose escalation trial directly supports
our ongoing development plans for RPL554 and we look forward to
enrolling patients in these, and potentially additional countries,
subject to further approvals,” said Jan-Anders Karlsson, PhD, CEO
of Verona Pharma. “This four-week, 400-patient study is an
important step forward in evaluating the potential of RPL554 as a
promising first-in-class treatment option for the 210 million
people around the world who suffer from COPD on an ongoing
basis.”
This clinical trial is part of Verona Pharma’s
global strategic services agreement with QuintilesIMS to provide
core clinical trial services for RPL554 clinical development
programs, as well as provide additional insights to inform
development and commercial strategy.
About Chronic Obstructive Pulmonary
Disease
Chronic obstructive pulmonary disease (COPD) is
a progressive respiratory disease for which there is no cure. The
condition damages the airways and the lungs, leading to cough,
mucus secretion and shortness of breath, impacting a person's
ability to perform daily activities. According to the World Health
Organization, COPD is the third leading cause of death globally,
with 210 million people worldwide suffering from the
disease. Current therapies to treat COPD are aimed at reducing
and controlling symptoms. Despite the wide availability of these
therapies, many COPD patients continue to suffer acute periods of
worsening symptoms known as exacerbations. In the U.S. alone, these
exacerbations are associated with approximately 1.5 million
emergency department visits, 687,000 hospitalizations, and 129,000
deaths per year. The total annual medical costs related to COPD in
the U.S. were estimated to be $32 billion in 2010, and are
projected to rise to $49 billion in 2020.
About Verona Pharma plc
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercialising
innovative therapies 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) and cystic fibrosis (CF), 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, including, but not limited to,
statements regarding the design of the Phase 2b clinical trial of
RPL554, the timing of the commencement of the Phase 2b clinical
trial and availability of top-line data for the Phase 2b clinical
trial, the importance of the Phase 2b clinical trial to our
development plans for RPL554, the potential of RPL554 as a
promising first-in-class treatment option for COPD, plans to enrol
patients in other countries subject to approvals, and projected
medical costs for COPD.
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 following: our
limited operating history; our need for additional funding to
complete development and commercialization of RPL554, which may not
be available and which may force us to delay, reduce or eliminate
our development or commercialization efforts; the reliance of our
business on the success of RPL554, our only product candidate under
development; economic, political, regulatory and other risks
involved with international operations; the lengthy and expensive
process of clinical drug development, which has an uncertain
outcome; serious adverse, undesirable or unacceptable side effects
associated with RPL554, which could adversely affect our ability to
develop or commercialize RPL554; potential delays in enrolling
patients, which could adversely affect our research and development
efforts; we may not be successful in developing RPL554 for multiple
indications; our ability to obtain approval for and commercialize
RPL554 in multiple major pharmaceutical markets; misconduct or
other improper activities by our employees, consultants, principal
investigators, and third-party service providers; material
differences between our “top-line” data and final data; our
reliance on third parties, including clinical investigators,
manufacturers and suppliers, and the risks related to these
parties’ ability to successfully develop and commercialize RPL554;
and lawsuits related to patents covering RPL554 and the potential
for our patents to be found invalid or unenforceable. These and
other important factors under the caption “Risk Factors” in our
final prospectus filed with the Securities and Exchange Commission
(“SEC”) on April 28, 2017 relating to our Registration Statement on
Form F-1, and our other reports filed with the SEC, 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.
For further information, please contact:
Verona Pharma plc |
Tel: +44 (0)20 3283
4200 |
Jan-Anders Karlsson,
Chief Executive Officer |
info@veronapharma.com |
|
|
N+1 Singer (Nominated
Adviser and UK Broker) |
Tel: +44 (0)20 7496
3000 |
Aubrey Powell / James
White |
|
|
|
ICR, Inc. (US Media and
Investor Enquiries) |
|
Darcie Robinson |
Tel: +1 203 682
8379 |
|
Darcie.Robinson@icrinc.com |
Stephanie
Carrington |
Tel: +1 646 277
1282 |
|
Stephanie.Carrington@icrinc.com |
|
|
FTI Consulting (UK
Media and Investor Enquiries) |
Tel: +44 (0)20 3727
1000 |
Simon Conway /
Stephanie Cuthbert / Natalie Garland-Collins |
veronapharma@fticonsulting.com |
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