Verona Pharma plc Verona Pharma Reports Patient Enrollment Progressing Ahead Of Schedule In Ongoing Phase 2b Clinical Trial O...
November 07 2017 - 2:00AM
UK Regulatory
TIDMVRP
Top-line data from the study now expected in mid-2018
LONDON, Nov. 07, 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 it has enrolled more than
200 patients in its ongoing Phase 2b study to evaluate RPL554 for the
maintenance treatment of chronic obstructive pulmonary disease (COPD).
The four-week, double-blind, placebo-controlled, parallel group Phase 2b
study is expected to enroll in total approximately 400 patients with
moderate-to-severe COPD at a number of sites across Europe to
investigate the efficacy, safety, and dose-response of nebulized RPL554
as a maintenance treatment for COPD. RPL554 is being dosed twice-daily
and patients are required to withhold their regular long-acting
bronchodilator therapy for the duration of the study. The primary
endpoint of the study is improvement in lung function, as measured by
forced expired volume in one second (FEV(1) ), after dosing with RPL554
or placebo. The secondary endpoints are morning trough FEV(1) , COPD
daily symptoms, dyspnea scale, and the St. George's Respiratory
Questionnaire (SGRQ), a COPD specific quality of life scale.
"We are pleased to be making excellent progress in this important study
as we have exceeded the 50 percent recruitment milestone and are
enrolling ahead of schedule," said Jan-Anders Karlsson, PhD, CEO of
Verona Pharma. "We are on track to complete enrollment faster than our
original timeline, and are confident of now reporting top-line data in
mid-2018, sooner than our previous guidance of 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
maintenance treatment of COPD patients and for the treatment of patients
with cystic fibrosis.
In previous clinical trials, RPL554 has been observed to result in
bronchodilatory effects when used alone or as an add-on treatment to
other COPD bronchodilators. It has shown clinically meaningful and
statistically significant improvements in lung function when
administered in addition to frequently used short- and long-acting
bronchodilators compared with such bronchodilators administered as a
single agent. In addition, RPL554 has shown anti-inflammatory effects in
a standard challenge study with COPD-like inflammation in human
subjects. In these studies, RPL554 has been well tolerated.
About COPD
Chronic obstructive pulmonary disease (COPD) is a progressive and
life-threatening respiratory disease for which there is no cure.(1) The
condition damages the airways and the lungs, leading to persistent
breathlessness, impacting a person's daily life and their ability to
perform simple activities such as walking a short flight of stairs or
carrying a suitcase.(1) Although COPD is thought to be underdiagnosed,
globally, around 384 million people suffer from the disease.(1,[2])
This number, according to the World Health Organization (WHO), is likely
to increase in coming years, with estimates that COPD will become the
third leading cause of death worldwide by 2030.(1,[3]) Current COPD
therapies focus on reducing and controlling symptoms. Yet, despite the
wide availability of these treatments, many patients continue to suffer
acute periods of worsening symptoms known as exacerbations. These
exacerbations often lead to emergency department visits or hospital
admissions, and are also associated with high mortality.(4) In the
United States alone, the 2010 total annual medical costs related to COPD
were estimated to be $32 billion, and are projected to rise to $49
billion in 2020.(5)
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. 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 administered in addition
to frequently used short- and long-acting bronchodilators as compared to
such bronchodilators administered as a single agent. Verona Pharma is
developing RPL554 for the treatment of chronic obstructive pulmonary
disease (COPD), 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 Officer info@veronapharma.com
Stifel Nicolaus Europe Limited Tel: +44 (0) 20 7710 7600
(Nominated Adviser and UK Broker) SNELVeronaPharma@stifel.com
Stewart Wallace / Jonathan Senior / Ben
Maddison
FTI Consulting (UK Media and Investor Tel: +44 (0)20 3727 1000
enquiries)
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.com
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
___________________
(1) World Health Organization. Chronic Obstructive Pulmonary Disease.
http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed September
2017.
(2) Adeloye D, Chua S, et al. Global and regional estimates of COPD
prevalence: Systematic review and meta-analysis. J Glob Health 2015;
5(2): 020415.
(3) World Health Organization. Burden of COPD.
http://www.who.int/respiratory/copd/burden/en/. Accessed September 2017.
(4) COPD Foundations. Characteristics of COPD Patients Using United
States Emergency Care or Hospitalization.
https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization.
Accessed September 2017.
(5) Center for Disease Control. Increase Expected in Medical Costs for
COPD. https://www.cdc.gov/features/ds-copd-costs/. Accessed September
2017.
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
November 07, 2017 02:00 ET (07:00 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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