Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, announces that it will present new subgroup analysis from
Phase 2b trials with nebulized ensifentrine in chronic obstructive
pulmonary disease (“COPD”) at the European Respiratory Society
(“ERS”) International Congress on Tuesday, September 8, 2020. The
abstracts are available on the ERS website and will be published in
a supplement of the September 2020 edition of the peer reviewed
journal, European Respiratory Journal.
Tara Rheault, Vice President, R&D and Global
Project Management at Verona Pharma, will present subgroup analysis
of Phase 2b data, first reported by Verona Pharma on January 13,
2020, and March 26, 2018, demonstrating that nebulized ensifentrine
as monotherapy or added on to tiotropium (Spiriva® Respimat®),
a long acting anti-muscarinic (“LAMA”) bronchodilator, improves
lung function in moderate to severe COPD patients regardless of
smoking status or history of chronic bronchitis over 4 weeks.
In addition to the oral presentation, Verona
Pharma will highlight data demonstrating that nebulized
ensifentrine added on to tiotropium over 4 weeks improved lung
function, symptoms and quality of life in moderate to severe COPD
patients who were either reversible (≥12% and 200 mL) to albuterol
and non-reversible (<12% or 200 mL) at screening compared to
placebo added on to tiotropium. Importantly, in non-reversible
patients, a large, clinically meaningful and statistically
significant improvement in QoL as measured by SGRQ‑C Total Score
was observed.
Details of Verona Pharma’s oral presentation and
abstracts are listed below with links to the ERS website.
Oral Presentation OA4787:
Ensifentrine, a dual PDE3/PDE4 inhibitor, improves FEV11 regardless
of smoking status or history of chronic bronchitis
Presenter: Tara Rheault, Vice President, R&D
and Global Project Management, Verona Pharma Channel
2: Cutting edge science: novel molecules and mechanisms of
airway diseases Session 415Date /
Time: Tuesday September 8, 2020 at 6:21 PM CEST / 5:21 PM
BST / 12:15 PM ET
Poster PA988: Ensifentrine added on to
tiotropium significantly improves lung function, symptoms and QoL
in symptomatic COPD patients regardless of baseline reversibility
Presenter: Kathleen Rickard, M.D., Chief Medical
Officer, Verona PharmaPre-Congress Content:
Clinical studies of COPD: combination inhalers and much more
Session 84
1 FEV1: Forced Expiratory Volume in one second,
a standard measure of lung function
About Ensifentrine
Ensifentrine (RPL554) is an investigational,
first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 (PDE3 and PDE4). This dual inhibition
enables it to combine both bronchodilator and anti-inflammatory
effects in one compound. Ensifentrine has demonstrated 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 1,300
people to date.
About Verona Pharma
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. 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. The Company plans to initiate
its Phase 3 clinical program ENHANCE (Ensifentrine as a Novel
inHAled Nebulized COPD thErapy) later in 2020 for nebulized
ensifentrine for COPD maintenance treatment. The Company
raised gross proceeds of $200 million through a private placement
in July 2020 and expects the funds to support its operations
and Phase 3 clinical program into 2023. Two
additional formulations of ensifentrine are currently in Phase 2
development for the treatment of COPD: dry powder inhaler (“DPI”)
and pressurized metered-dose inhaler. Ensifentrine also has
potential applications in COVID-19, cystic fibrosis, asthma and
other respiratory diseases. For more information, please
visit www.veronapharma.com.
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 development and potential of ensifentrine,
the initiation, progress and timing of clinical trials,
ensifentrine as a first-in-class phosphodiesterase 3 and 4
inhibitor, and plans to develop ensifentrine for the treatment of
COVID-19, 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; 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; the loss of any
key personnel and our ability to recruit replacement personnel, as
well as the impact of our management team transition; 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; lawsuits related to patents covering ensifentrine and
the potential for our patents to be found invalid or unenforceable;
the impact of the COVID-19 pandemic on our operations, the
continuity of our business and general economic conditions; and our
vulnerability to natural disasters, global economic factors and
other unexpected events, including health epidemics or pandemics
like COVID-19.
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 February 27,
2020, under the caption “Supplemental Risk Factor Disclosures” in
our Report on Form 6-K filed with the SEC on April 30, 2020, under
the caption “Risk Factors” in our Registration Statement on Form
F-1 filed with the SEC on August 17, 2020, 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, operational review, outlook and financial review.
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 |
Victoria Stewart, Director of
Communications |
|
|
|
N+1 Singer
(Nominated Adviser and UK Broker) |
Tel: +44 (0)20 7496 3000 |
Aubrey Powell / George Tzimas /
Iqra Amin (Corporate
Finance) |
|
Tom Salvesen (Corporate
Broking) |
|
|
|
Optimum Strategic
Communications (European Media and Investor
Enquiries) |
Tel: +44 (0)203 950 9144
verona@optimumcomms.com |
Mary Clark / Eva Haas / Shabnam
Bashir |
|
|
|
Argot Partners
(US Investor Enquiries) |
Tel: +1 212-600-1902
verona@argotpartners.com |
Kimberly Minarovich / Michael
Barron |
|
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