Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, announces that six abstracts presenting clinically
relevant findings from its clinical trials with first-in-class
development candidate, ensifentrine, for the treatment of chronic
obstructive pulmonary disease (“COPD”) have been accepted by the
American Thoracic Society International Conference (“ATS”) 2020.
The abstracts are published on the ATS website and today in the
peer reviewed publication, American Journal of Respiratory and
Critical Care Medicine.
The presentations include a late-breaking
abstract that expands on Phase 2b efficacy and symptom data first
announced by the Company on January 13, 2020 where nebulized
ensifentrine added on to tiotropium demonstrated clinically and
statistically significant dose-dependent improvements in lung
function as well as COPD symptoms. Other abstracts include clinical
data from three previous studies that demonstrate ensifentrine’s
potential in additional treatment settings and with the dry powder
formulation. These include further analyses of positive Phase 2b
efficacy (subgroup analysis), symptom (responder analysis) and
safety data with nebulized ensifentrine as a monotherapy in
patients with COPD as well as an analysis of additional lung
function improvement when nebulized ensifentrine was added to dual
COPD therapy. In addition, one abstract analyses positive Phase 2
data with ensifentrine in a dry powder inhaler formulation dosed
over 7 days in patients with COPD.
Gary T. Ferguson, MD, Director of the Pulmonary
Research Institute of Southeast Michigan and Principal Investigator
in the Phase 2b study that evaluated ensifentrine added on to
tiotropium commented: “Ensifentrine has demonstrated significant
additional benefits to bronchodilation, symptoms and quality of
life when used as an add-on therapy to tiotropium. I am especially
encouraged by the significant improvements in quality of life
measurements over the 4 week treatment period. This is very
important for patients who remain symptomatic despite using
standard COPD medications and supports the potential for
ensifentrine to provide a meaningful difference in the treatment of
COPD patients.”
Details of Verona Pharma’s six abstracts are
listed below with links to the ATS website.
Late-breaking Abstract: A4213 –
Ensifentrine Provides Significant and Clinically Meaningful
Bronchodilation and Quality of Life Improvement on Top of
Tiotropium in Symptomatic COPD Patients in a 4-Week Dose-Ranging
Study Participant: Gary Ferguson, Principal
Investigator, Pulmonary Research Institute of Southeast Michigan,
Farmington Hills, MI, US Session: B93 – Late
Breaking Clinical Trials in Airway Diseases
Abstract: A4578 – Responder
Analyses For Symptom And QoL (E-RS, TDI And SGRQ-C) Improvement
With Nebulized Ensifentrine Dosed Twice Daily Over 4 Weeks
Participant: Tara Rheault, Vice President, R&D
and Global Project Management, Verona Pharma
Session: C23. Assessment of Outcome Risk in
Obstructive Lung Disease
Abstract: A3323 – Safety of
Ensifentrine, a Dual PDE3/4 Inhibitor: Results of Reported GI and
CV Events from a Four Week Randomized, Controlled Trial
Participant: Kathleen Rickard, Chief Medical
Officer, Verona Pharma Session: B41. Therapeutic
Intervention, Quality Improvement and Treatment Adherence in
Obstructive Lung Disease
Abstract: A4297 – Bronchodilation
and Symptom Improvement with Ensifentrine, A Dual PDE3/4 Inhibitor:
Sub-Group Analyses of a Four Week Randomized, Controlled Trial in
Patients with COPD Participant: Tara Rheault, Vice
President, R&D and Global Project Management, Verona Pharma
Session: B103. Treatment of Obstructive Lung
Disease
Abstract: A4298 – Additional
Bronchodilation by Ensifentrine, A Dual PDE3/4 Inhibitor, When
Combined with a LAMA/LABA in Patients with Moderate to Severe COPD
Participant: Kathleen Rickard, Chief Medical
Officer, Verona Pharma Session: B103. Treatment of
Obstructive Lung Disease
Abstract: A4296 – Ensifentrine, A
Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Provides Effective
Bronchodilation in COPD When Administered Twice Daily Over 7 Days
Via a Dry Powder Inhaler Participant: Tara
Rheault, Vice President, R&D and Global Project Management,
Verona Pharma Session: B103. Treatment of
Obstructive Lung Disease
About COPD
COPD 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. US sales of medicines used for
chronic maintenance therapy of COPD were $9.6 billion in 2019.
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 Ensifentrine
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, 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
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. Verona Pharma is currently evaluating
three formulations of ensifentrine for the treatment of COPD in
Phase 2 clinical trials: 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 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, 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; and our vulnerability to natural disasters, global
economic factors and other unexpected events, including health
epidemics or pandemics like the novel coronavirus (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, 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 |
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 / 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)203 950 9144 verona@optimumcomms.com |
Mary Clark / Eva Haas / Shabnam Bashir |
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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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