Verona Pharma Presents Expanded Analysis of Ensifentrine Clinical Data in COPD Maintenance Treatment at American Thoracic Soc...
May 20 2019 - 10:15AM
Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, today presents clinically relevant findings from its
chronic obstructive pulmonary disease (“COPD”) clinical trial
program with lead product candidate, ensifentrine (RPL554), at the
American Thoracic Society International Conference (“ATS”) in
Dallas, TX. Positive results from the 4-week, 400-patient Phase 2b
study were initially reported in March 2018.
The expanded analysis is supportive of the
differentiated, dual mechanism of action of ensifentrine, as both a
bronchodilator and an anti-inflammatory agent in a single compound.
It provides further evidence of the potential for ensifentrine to
provide significant symptom benefits to patients.
“These encouraging data suggest that
ensifentrine’s dual mode of action combining anti-inflammatory and
bronchodilator effects will lead to additional symptom benefits in
COPD patients,” said Dave Singh, M.D., Professor of Clinical
Pharmacology and Respiratory Medicine, Medicines Evaluation Unit,
University of Manchester, and presenter of the poster at ATS.
“Importantly, ensifentrine was highly effective in improving
symptoms independently of the magnitude of the bronchodilator
response, suggesting that the activity of the PDE3/4 inhibitor is
different to that of available bronchodilators when used alone or
in combination. The anti-inflammatory activity may be responsible
for this effect as it cannot be explained by bronchodilation
alone.”
Details of the expanded analysis are available
on Verona Pharma’s website here.Details of the abstract were
provided in the announcement dated May 2, 2019 and are available at
the American Thoracic Society website
athttps://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A3846
Ensifentrine is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 that has been
shown in several previous clinical studies to act both as a
bronchodilator and an anti-inflammatory agent in a single compound.
It is currently being evaluated in a further Phase 2b clinical
trial as an add-on to standard therapy for the maintenance
treatment of COPD, with data anticipated around year-end and
expected to inform dose selection for Phase 3 trials. Verona Pharma
expects to hold an end-of-Phase 2 meeting with the FDA in the first
half of 2020 and plans to enter Phase 3 trials in 2020.
In addition to advancing the nebulized
formulation, Verona Pharma has also developed dry powder inhaler
(“DPI”) and pressurized metered dose inhaler (“pMDI”) formulations
of ensifentrine. In an ongoing Phase 2 clinical trial, the DPI
formulation demonstrated dose-dependent, significant
bronchodilation following a single dose, and is currently being
evaluated over one week of twice-daily treatment, with top-line
data expected in the third quarter this year. The pMDI formulation
is planned to enter clinical evaluation in a Phase 2 study in COPD
patients later this quarter.
About COPDCOPD is a progressive and
life-threatening respiratory disease without a cure. The World
Health Organization estimates that it will become the third leading
cause of death worldwide by 2030. The condition damages the airways
and the lungs, leading to debilitating breathlessness that has a
devastating impact on performing basic daily activities such as
getting out of bed, showering, eating and walking. 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. About 800,000 US COPD patients on dual/triple
inhaled therapy (LAMA/LABA +/- ICS) remain uncontrolled,
experiencing symptoms that impair quality of life. These patients
urgently need better treatments.
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, ensifentrine (RPL554), is
a first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 that has been shown to act as both a
bronchodilator and an anti-inflammatory agent in a single compound.
Ensifentrine is currently in Phase 2b clinical development for the
maintenance treatment of COPD and is planned to enter Phase 3
trials for this indication in 2020. Verona Pharma may also develop
ensifentrine for the treatment of cystic fibrosis and asthma.
In Phase 2 clinical studies in patients with
moderate to severe COPD, ensifentrine has shown significant and
clinically meaningful improvements in both lung function and COPD
symptoms, including breathlessness. In addition, ensifentrine has
further improved lung function and reduced lung volumes in patients
taking standard short- and long-acting bronchodilator therapy,
including maximum bronchodilator treatment with dual/triple
therapy. Ensifentrine has been well tolerated in clinical trials
involving more than 800 people to date.
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 value of
trial results presented at ATS, ensifentrine as a new complementary
treatment for patients with COPD, statements that there is an
opportunity for additional symptom improvement via ensifentrine’s
novel mechanism of action, the expectation that our Phase 2b study
will inform the dose selection for Phase 3, the expected timelines
for trial data, the end-of-Phase 2 FDA meeting and initiation of
Phase 3, the future clinical development and positioning of
ensifentrine, and the projected annual medical costs related to
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 ensifentrine, 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 ensifentrine, 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 ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; potential delays in enrolling patients, which could
adversely affect our research and development efforts; we may not
be successful in developing ensifentrine for multiple
indications; our ability to obtain approval for and commercialize
ensifentrine 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
ensifentrine; and lawsuits related to patents covering ensifentrine
and the potential for our patents to be found invalid or
unenforceable. These and other important factors under the caption
“Risk Factors” in our Annual Report on Form 20-F filed with the
Securities and Exchange Commission (“SEC”) on March 19, 2019, 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 |
Victoria Stewart, Director of Communications |
|
|
|
N+1 Singer |
Tel: +44 (0)20 3283 4200 |
(Nominated Adviser and UK Broker)Aubrey Powell /Jen Boorer /Iqra
Amin (Corporate Finance) Mia Gardener (Corporate Broking)
|
|
Optimum Strategic Communications (European Media
and Investor enquiries) |
|
Mary Clark, Anne Marieke Ezendam, Hollie Vile |
Tel: +44 (0) 203 922 0891verona@optimumcomms.com |
Westwicke, an ICR Company (US Media and Investor
enquiries) |
|
Darcie Robinson |
Tel: +1 203-919-7905darcie.robinson@icrinc.com |
Stephanie Carrington |
Tel. +1 646-277-1282stephanie.carrington@icrinc.com |
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