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 (FEV1), after dosing with RPL554 or placebo. The
secondary endpoints are morning trough FEV1, 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 COPDChronic 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 StatementsThis
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 (Nominated Adviser and UK Broker) |
Tel:
+44 (0) 20 7710 7600 SNELVeronaPharma@stifel.com |
Stewart Wallace /
Jonathan Senior / Ben Maddison |
|
|
|
FTI Consulting (UK
Media and Investor enquiries) |
Tel: +44 (0)20 3727
1000 |
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.
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