Verona Pharma to Present Phase 2 Data with Ensifentrine Dry Powder Inhaler Formulation in COPD at European Respiratory Societ...
19 Setembro 2019 - 3:00AM
Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
biopharmaceutical company focused on respiratory diseases,
announces that it will present positive interim data from a Phase 2
trial with its dry powder inhaler formulation of ensifentrine in
chronic obstructive pulmonary disease (“COPD”) at the European
Respiratory Society (“ERS”) International Congress on Sunday,
September 29, 2019 at 10:15 AM CEST.
These interim single dose data were first
announced in March 2019 and followed by further positive results in
August 2019 where all the primary and secondary lung function
endpoints were met in the Phase 2 trial. The magnitude of
improvement in lung function and duration of action were highly
statistically significant and support twice daily dosing of
ensifentrine for the treatment of COPD. Results from the 7-day
Phase 2 trial are available on Verona Pharma’s website here.
Details of Verona Pharma’s oral presentation are listed below
and the abstract is available to the public online via the ERS
website here.
Oral Presentation: Ensifentrine, a novel dual
phosphodiesterase (PDE) 3 and 4 inhibitor, provides effective
bronchodilation when administered by dry powder inhaler in COPD
Presenter: Tara Rheault, Vice President, R&D
and Global Project Management, Verona Pharma Session
53: COPD clinical trials: new molecules and novel insights
Date / Time: Sunday September 29, 2019 at
10:15 AM CEST / 9:15 AM BST / 4:15 AM ET Location:
IFEMA Exhibition Centre, Madrid; Room 6F
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 annual medical costs related to COPD are
projected to rise to $49 billion in 2020. About 1.2 million 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 plcVerona 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.
Three formulations of ensifentrine are under development for the
treatment COPD: nebulized 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; a dry
powder inhaler (“DPI”) formulation reported positive Phase 2 data
in August 2019; a pressurized metered-dose inhaler (“pMDI”)
formulation expects to report Phase 2 single dose data in the
second half of 2019, with final data expected in the first quarter
of 2020. Verona Pharma may also develop ensifentrine for the
treatment of cystic fibrosis and asthma.
For more information, please visit
veronapharma.com
About EnsifentrineNebulized
ensifentrine has shown significant and clinically meaningful
improvements in both lung function and COPD symptoms, including
breathlessness, in Verona Pharma’s prior Phase 2 clinical studies
in patients with moderate-to-severe COPD. In addition, nebulized
ensifentrine showed 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, the development of ensifentrine, the progress and
timing of clinical trials and data, estimates of medical costs for
COPD, ensifentrine as a first-in-class phosphodiesterase 3 and 4
inhibitor, and plans to develop ensifentrine for the treatment of
cystic fibrosis and asthma.
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 and the
completion of our Phase 2b trial; 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 |
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N+1 Singer (Nominated Adviser and UK Broker) |
Tel: +44 (0)20 3283 4200 |
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate Finance) |
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Mia Gardner (Corporate Broking) |
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Optimum Strategic Communications(European Media
and Investor Enquiries) |
Tel: +44 (0)20 950 9144 verona@optimumcomms.com |
Mary Clark / Anne Marieke Ezendam / Hollie Vile |
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Argot Partners(US Investor enquiries) |
Tel: +1 212-600-1902verona@argotpartners.com |
Stephanie Marks |
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