Verona Pharma to Present Phase 2b COPD Symptom and Quality of Life Data with Ensifentrine at CHEST 2020
October 13 2020 - 2:00AM
Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, announces that it will present new analyses from a Phase
2b clinical trial with nebulized ensifentrine in chronic
obstructive pulmonary disease (“COPD”) at CHEST Annual Meeting
(“CHEST”) 2020 taking place on October 18-21. The data are
published in the CHEST Annual Meeting online supplement.
The posters present further analysis of Phase 2b
data, first reported by Verona Pharma on January 13, 2020,
demonstrating that nebulized ensifentrine added to tiotropium
(Spiriva® Respimat®), a long acting anti-muscarinic (“LAMA”)
bronchodilator, provides meaningful additional improvement in
quality of life as measured by St. George’s Respiratory
Questionnaire: COPD (SGRQ-C). This was shown in symptomatic COPD
patients over 4 weeks, including statistically significant
improvement in both activity and impacts subscales compared to
placebo added on to tiotropium. Importantly, a responder analysis
of the proportion of patients achieving a clinically important
difference in quality of life on the SGRQ-C showed responses in
favor of ensifentrine, which were particularly notable in COPD
patients who were not reversible to albuterol. An evaluation of
inspiratory capacity over 4 weeks demonstrated a clinically
meaningful and statistically significant improvement in inspiratory
capacity (“IC”). Improvements in IC have been shown to correlate
with improvements in dyspnea, suggesting that ensifentrine improves
symptoms and quality of life via a physiological mechanism.
In addition to the Phase 2b data with nebulized
ensifentrine, Verona Pharma will highlight Phase 2 data with a
pressurized metered dose inhaler (“pMDI”) formulation of
ensifentrine. This data showed a rapid and meaningful
bronchodilatory response in COPD patients following a single dose
of ensifentrine pMDI. This effect was sustained for 12 hours. Data
from this study were first reported on March 31, 2020. Notably, the
Company will also present pre-clinical data demonstrating the
anti-inflammatory effects of ensifentrine, which further support
its dual mechanism of action as an inhibitor of phosphodiesterases
(“PDE”) 3 and 4.
Details of Verona Pharma’s abstracts are listed
below.
e-Poster:
P1491 Ensifentrine added to tiotropium over 4 weeks provides
additional improvement in COPD quality of
lifeAuthor: Kathleen Rickard,
M.D., CMO, Verona PharmaSession: Obstructive Lung
Disease Posters
e-Poster:
P1490 Ensifentrine added on to tiotropium significantly improves
inspiratory capacity in patients with symptomatic COPD
Author: Kathleen Rickard, M.D.,
CMO, Verona PharmaSession: Obstructive Lung
Disease Posters
e-Poster:
P1489 Ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4
inhibitor, provides effective bronchodilation when administered by
metered dose inhaler in patients with COPD
Presenter: Tara Rheault, Ph.D., Vice President,
R&D and Global Project Management, Verona
PharmaSession: Obstructive Lung Disease
Posters
e-Poster:
P1944 Anti-inflammatory pharmacology of
ensifentrinePresenter: Tara Rheault, Ph.D., Vice
President, R&D and Global Project Management, Verona
PharmaSession: Respiratory Care Posters
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(U.S. Investor Enquiries) |
Tel: +1
212-600-1902verona@argotpartners.com |
Kimberly Minarovich / Michael
Barron |
|
About COPD
COPD is a progressive and life-threatening
respiratory disease without a cure. It is the third leading cause
of death globally, according to the World Health Organization. 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. U.S. sales of medicines used for
chronic maintenance therapy of COPD were $9.6 billion in 2019.
About 1.2 million U.S. 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) 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 also activates the Cystic
Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is
beneficial in reducing mucous viscosity and improving mucociliary
clearance. Ensifentrine’s mechanism of action has the potential to
alleviate respiratory symptoms such as breathlessness and cough and
work against inflammation associated with COPD or inflammation
triggered by viruses.
Ensifentrine has demonstrated significant and
clinically meaningful improvements in both lung function and
symptoms, including breathlessness, in Verona Pharma’s Phase 2
clinical studies in patients with moderate to severe Chronic
Obstructive Pulmonary Disease (“COPD”). In addition, nebulized
ensifentrine showed further improved lung function and reduced lung
volumes in COPD 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 subjects 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 is evaluating nebulized
ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine
as a Novel inHAled Nebulized COPD thErapy”) 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 (“pMDI”). Ensifentrine is in a
pilot clinical study in patients hospitalized with COVID-19 and 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. 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. 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.
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