Verona Pharma plc Verona Pharma Doses First Patients In Phase 2b Clinical Trial Of Rpl554 For Copd Maintenance Treatment
26 July 2017 - 4:00PM
UK Regulatory
TIDMVRP
Dose escalation trial will evaluate RPL554 in approximately 400 COPD
patients
LONDON, July 26, 2017 (GLOBE NEWSWIRE) -- 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 that the first patients have
been dosed in a Phase 2b clinical trial evaluating RPL554 as a
maintenance treatment for chronic obstructive pulmonary disease
("COPD"). Verona Pharma expects to report top-line data from this trial
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.
The four-week, dose-ranging trial is planned to enroll approximately 400
patients with COPD to investigate the efficacy, safety, and
dose-response of nebulized RPL554 as a maintenance treatment for the
disease. The primary endpoint of this double-blind, placebo-controlled,
parallel group study is improvement in lung function with RPL554
compared to placebo, as measured by FEV(1) , a standard measure of
exhaled breath volume used to evaluate respiratory function.
The trial is being performed at a number of sites across Europe and 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.
"Dosing our first patients in this larger four-week Phase 2b trial is an
important step forward in the evaluation of nebulized RPL554 as a novel
therapy for COPD patients with significant unmet medical needs," said
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "The clinical data
generated to date and the mechanism of action of RPL554 makes it a
promising first-in-class treatment option. We look forward to working
with patients and healthcare providers across the trial sites to gather
meaningful data and insights, and expect to report top-line results from
this study in the second half of 2018."
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 and has been well tolerated in clinical trials.
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 commercializing 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 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, and the value of the data and insights that may be gathered from
the Phase 2b clinical trial.
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 info@veronapharma.com
Officer
N+1 Singer (Nominated Adviser and UK Tel: +44 (0)20 7496 3000
Broker)
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 Tel: +44 (0)20 3727 1000
Enquiries)
Simon Conway / Stephanie Cuthbert / veronapharma@fticonsulting.com
Natalie Garland-Collins
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Verona Pharma plc via Globenewswire
http://www.veronapharma.com/
(END) Dow Jones Newswires
July 26, 2017 02:00 ET (06:00 GMT)
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