Verona Pharma plc Verona Pharma To Present Phase 2b Copd Symptom And Quality Of Life Data With Ensifentrine At Chest 2020
2020年10月13日 - 3:00PM
RNSを含む英国規制内ニュース (英語)
TIDMVRP
Posters highlight ensifentrine's potential to provide rapid benefits
LONDON and RALEIGH, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) -- 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
https://www.globenewswire.com/Tracker?data=SUTCRp0UxBsvD-tUy10edVFo38iyIwfBiWcu0Y7IcF-iZ-NtPJMrZVYLl9hzaHYzmZYGiZZbh4HXv0Vz9hu5hfuBapB0iYBQkPw3SGybTYqhciK8uHynt0nW3WrwHVykLwNfarD15NAYG80n5VZCtTwlB3H5nMGuT24v5KAzuYjs-FlbHKE-qlmTmeMuNTQr
, demonstrating that nebulized ensifentrine added to tiotropium
(Spiriva(R) Respimat(R) ), 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
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. 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 life
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Author: Kathleen Rickard, M.D., CMO, Verona Pharma
Session: Obstructive Lung Disease Posters
e-Poster: P1490
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Ensifentrine added on to tiotropium significantly improves inspiratory
capacity in
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patients with
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symptomatic COPD
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Author: Kathleen Rickard, M.D., CMO, Verona Pharma
Session: Obstructive Lung Disease Posters
e-Poster: P1489
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Ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor,
provides effective bronchodilation when administered by metered dose
inhaler in patients with COPD
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Presenter: Tara Rheault, Ph.D., Vice President, R&D and Global Project
Management, Verona Pharma
Session: Obstructive Lung Disease Posters
e-Poster: P1944
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A
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nti-inflammatory pharmacology of ensifentrine
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Presenter: Tara Rheault, Ph.D., Vice President, R&D and Global Project
Management, Verona Pharma
Session: 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 Tel: +44 (0)20 7496 3000
(Nominated Adviser and UK Broker)
Aubrey Powell / George Tzimas / Iqra Amin
(Corporate Finance)
Tom Salvesen (Corporate Broking)
Optimum Strategic Communications Tel: +44 (0)203 950 9144
(European Media and Investor Enquiries) verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir
Argot Partners Tel: +1 212-600-1902
(U.S. Investor Enquiries) verona@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.
(END) Dow Jones Newswires
October 13, 2020 02:00 ET (06:00 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Verona Pharma (LSE:VRP)
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