Verona Pharma plc Verona Pharma Receives Regulatory Approval To Commence Phase 2b Clinical Trial Of Rpl554 For Copd Maintenan...
27 June 2017 - 4:00PM
UK Regulatory
TIDMVRP TIDMVRP
Dose escalation trial will evaluate RPL554 as a maintenance treatment in
approximately 400 COPD patients
LONDON, June 27, 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 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 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
June 27, 2017 02:00 ET (06:00 GMT)
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