Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, announces publication of Phase 2b clinical trial results
for ensifentrine as a maintenance treatment for chronic obstructive
pulmonary disease (“COPD”) in the leading peer reviewed journal,
Respiratory Research. The study met its primary endpoint
demonstrating that ensifentrine produced clinically and
statistically significant improvements in lung function at all
doses. Also, clinically relevant secondary endpoints were met
including significant progressive improvements in COPD symptoms.
The paper, entitled “A dose-ranging study of the
inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in
COPD,” was published on-line here. Results from the 4-week
400-patient study were first reported in March 2018 and further
positive analysis was presented in May 2019 at the American
Thoracic Society International Conference.
Lead development candidate ensifentrine is a
first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 that has been shown to act both as an
anti-inflammatory and bronchodilator agent in a single compound. In
January 2020, Verona Pharma reported positive top-line results from
a second 4-week 400-patient Phase 2b study with nebulized
ensifentrine added on to inhaled tiotropium (Spiriva® Respimat®)
therapy in symptomatic COPD patients.
Dave Singh, M.D., Professor of Clinical
Pharmacology and Respiratory Medicine, Medicines Evaluation Unit,
University of Manchester, and Lead Investigator in the study
commented: “These encouraging data published in Respiratory
Research, combined with ensifentrine’s unique mode of action,
support its potential as a novel therapy to meet the high unmet
medical need in COPD. The improvements in patients’ symptoms,
including breathlessness, are particularly noteworthy.”
David Zaccardelli, Pharm. D., President and CEO
of Verona Pharma, said: “The compelling data from our two
successful Phase 2b studies in COPD, one in patients with no
background therapy and the second in symptomatic patients already
on maintenance therapy, are further evidence of ensifentrine’s
promising therapeutic potential. We look forward to discussing
these results, along with positive data from previous clinical
studies, in an End-of-Phase 2 meeting with the FDA, anticipated for
2Q 2020. We expect this meeting to provide key guidance with
respect to the design of our Phase 3 program.”
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 total 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, long-acting beta-agonist
(LABA)/long-acting muscarinic antagonist (LAMA) +/- inhaled
corticosteroid (ICS) remain uncontrolled, experiencing symptoms
that impair quality of life. These patients urgently need better
treatments.
About EnsifentrineNebulized
ensifentrine (RPL554) 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 1300
people to date.
About Verona
PharmaVerona 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. If successfully developed and
approved, Verona Pharma’s product candidate, ensifentrine, has the
potential to be the first therapy for the treatment of respiratory
diseases that combines bronchodilator and anti-inflammatory
activities in one compound. Verona Pharma is currently in Phase 2
development with three formulations of ensifentrine for the
treatment of COPD: nebulized, dry powder inhaler, and pressurized
metered-dose inhaler. Ensifentrine also has potential applications
in cystic fibrosis, asthma and other respiratory diseases. For more
information, please visit www.veronapharma.com.
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, data and meetings with the
FDA, the potential for ensifentrine to be a first-in-class
phosphodiesterase 3 and 4 inhibitor, and to be the first therapy
for the treatment of respiratory diseases to combine bronchodilator
and anti-inflammatory activities in one compound, the potential for
ensifentrine to have a significant impact on the treatment of COPD,
estimates of medical costs for COPD and the number of symptomatic
COPD patients, and the potential application of ensifentrine for
the treatment of cystic fibrosis, asthma and other respiratory
diseases.
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 clinical trials; 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; our future growth and ability to
compete depends on retaining our key personnel and recruiting
additional qualified personnel; material differences between our
“top-line” data and final data; our reliance on third parties,
including clinical research organizations, 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 |
David Zaccardelli, Chief Executive Officer |
info@veronapharma.com |
David Moskowitz, VP Capital Markets Strategy & Investor
Relations (Investor enquiries)Victoria Stewart, Director of
Communications (Media Enquiries) |
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N+1 Singer (Nominated Adviser and UK Broker) |
Tel: +44 (0)20 3283 4200 |
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance) |
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Tom Salvesen (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 / Eva Haas / Hollie Vile |
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Argot Partners(US Investor Enquiries) |
Tel: +1 212-600-1902verona@argotpartners.com |
Stephanie Marks / Kimberly Minarovich / Michael Barron |
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