Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the
“Company”), announces eight posters, including two mini oral
symposia, on additional analyses from its successful Phase 3
ENHANCE studies with ensifentrine for the treatment of chronic
obstructive pulmonary disease (“COPD”) will be presented at the
American Thoracic Society International Conference (“ATS”) 2024.
Pooled analysis demonstrating reductions in the rate and risk of
exacerbations with ensifentrine will be presented as part of the
‘Late Breaking Mini Symposium’ designed to highlight new
breakthroughs. The posters are published on the ATS website and in
the publication, American Journal of Respiratory and Critical
Care Medicine.
Ensifentrine is a novel selective dual inhibitor
of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3
and PDE4”) that combines bronchodilator and non-steroidal
anti-inflammatory effects in one molecule. The investigational
product is currently under review by the US FDA, and, if approved,
is expected to be the first novel inhaled mechanism for the
maintenance treatment of COPD in more than 20 years.
The posters are based on pooled analyses from
the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company
on December 20, 2022, and August 9,
2022, respectively. Ensifentrine met the primary endpoint
in both ENHANCE-1 and ENHANCE-2 demonstrating statistically
significant improvements in lung function across both primary and
secondary endpoints. In a pre-specified endpoint, ensifentrine
substantially reduced the rate and risk of moderate/severe
exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The
posters will summarize the efficacy and safety endpoints of
ensifentrine when added to a long-acting muscarinic antagonist
(“LAMA”) or a long-acting beta-agonist/inhaled corticosteroids
(“LABA/ICS”), reductions in the rate of exacerbations regardless of
eosinophil count and delayed progression of exacerbations, and the
impact of ensifentrine on improving dyspnea. In addition, the
Company will host an exhibition booth exploring the role of
phosphodiesterase (“PDE”) in inflammation and lung function
impairment in COPD as well as three innovation hub presentations
led by clinical experts.
Frank Sciurba, MD, Associate Professor of
Medicine at the University of Pittsburgh School of Medicine,
commented: “These pooled analyses from the ENHANCE studies provide
further evidence of ensifentrine’s potential to become an important
therapy in a broad population of COPD patients. The substantial
reduction in exacerbation rate and risk with ensifentrine is
particularly exciting for patients and physicians.”
Details of Verona Pharma’s posters and the
symposia are listed below and linked to the ATS website.
Late-Breaking Mini Symposium:
Ensifentrine Reduces Exacerbation Frequency and Delays Progression
from Gold B to Gold EPresenter: Frank Sciurba, MD,
University of Pittsburgh Medical CenterSession:
B14 – Late Breaking Abstracts: Science that will impact clinical
care
Mini Symposium: Ensifentrine
added on to LAMA Therapy Improved Lung Function and Reduced
Exacerbations in Symptomatic Subjects with Moderate-to-Severe
COPD Presenter: Mark
Dransfield, MD, University of Alabama Birmingham & Birmingham
VA Medical
CenterSession: C95 – New
clinical trial results in chronic lung disease
Poster: P624 – Ensifentrine, A
Novel, Selective Inhibitor of PDE3 and PDE4, Reduced
Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD
Regardless of Baseline Blood
EosinophilsParticipant: Frank
Sciurba, MD, University of Pittsburgh Medical
CenterSession: B52 – Evidence for therapeutic
strategies in COPD: from established to emerging
Poster: P625 – Ensifentrine
Added on to LABA/ICS Therapy Improved Lung Function and Reduced
Exacerbations in Symptomatic Subjects With Moderate-to-Severe
COPDPresenter: Nathan
Marchetti, MD, Thoracic Medicine and Surgery, Lewis Katz School of
Medicine at Temple UniversitySession: B52 –
Evidence for therapeutic strategies in COPD: from established to
emerging
Poster: P704 – Improvements in
Breathlessness, COPD Symptoms and Quality of Life Reported With
Ensifentrine in a Pooled Analysis of the ENHANCE
TrialsPresenter: Dave Singh,
Professor of Respiratory Pharmacology at the University of
ManchesterSession: A101 – Full metal jacket
targeting COPD and chronic airways disease
Poster: P901 – Ensifentrine
Added on to LAMA Therapy Improved COPD Symptoms and Quality of Life
in Subjects With Symptomatic Moderate-to-Severe
COPDPresenter: Ravi Kalhan,
MD, Pulmonology and Critical Care, Northwestern
UniversitySession: A27 – Emerging treatments
and therapeutic strategies in COPD: results of clinical trials and
observational studies
Poster: P909 – Ensifentrine, A
Novel, Selective Inhibitor of PDE3 and PDE4, Improved Dyspnea in
Subjects With Symptomatic, Moderate-to-Severe COPD Over 24
WeeksPresenter: Donald
Mahler, MD, Valley Regional Hospital in
ClaremontSession: A27 – Emerging treatments
and therapeutic strategies in COPD: results of clinical trials and
observational studies
Poster: P911 – Ensifentrine
Added on to LABA/ICS Therapy Reduced Dyspnea and Improved Quality
of Life in Subjects With Symptomatic Moderate-to-Severe
COPDPresenter: Antonio
Anzueto, MD, Medicine/Pulmonary Critical Care, South Texas Veterans
Healthcare System Session: A27 – Emerging
treatments and therapeutic strategies in COPD: results of clinical
trials and observational studies
About Verona Pharma
Verona Pharma is a biopharmaceutical company
focused on developing and commercializing innovative therapies for
the treatment of chronic respiratory diseases with significant
unmet medical needs. In the third quarter of 2023, the US Food and
Drug Administration accepted for review the Company’s NDA for
ensifentrine for the maintenance treatment of patients with COPD
and assigned a PDUFA target action date of June 26, 2024. If
approved, ensifentrine has the potential to become the first
inhaled non-steroidal therapy for the treatment of respiratory
diseases that combines bronchodilator and anti-inflammatory
activities in one molecule, and the first novel inhaled mechanism
for the maintenance treatment of COPD in more than 20 years. The
Company has evaluated nebulized ensifentrine in its Phase 3
clinical program ENHANCE (“Ensifentrine as a Novel inHAled
Nebulized COPD thErapy”) for COPD maintenance treatment.
Ensifentrine met the primary endpoint in both ENHANCE-1 and
ENHANCE-2 trials demonstrating statistically significant and
clinically meaningful improvements in lung function. In addition,
ensifentrine substantially reduced the rate and risk of COPD
exacerbations in a pooled analysis from ENHANCE-1 and ENHANCE-2.
Two additional formulations of ensifentrine have been evaluated in
Phase 2 trials for the treatment of COPD: dry powder inhaler
(“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a
fixed-dose combination formulation with ensifentrine and
glycopyrrolate, a LAMA, is currently under development, also for
the treatment of COPD. Ensifentrine also has potential applications
in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and
other respiratory diseases. For more information, please visit
www.veronapharma.com.
For further information please contact:
Verona Pharma plc |
US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 |
Victoria Stewart, Senior Director of Investor Relations and
Communications |
IR@veronapharma.com |
Argot PartnersUS Investor Enquiries |
Tel: +1-212-600-1902verona@argotpartners.com |
Ten Bridge CommunicationsInternational / US Media
Enquiries |
Tel: +1-312-523-5016tbcverona@tenbridgecommunications.com |
Leslie Humbel |
|
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 relating to the timing of the FDA’s potential approval
of the NDA for ensifentrine by the PDUFA date of June 26, 2024, or
at any other time, statements regarding the potential for
ensifentrine to be the first novel inhaled mechanism available for
the maintenance treatment of COPD in over 20 years, the first
therapy for the treatment of respiratory diseases to combine
bronchodilator and non-steroidal anti-inflammatory effects in one
molecule, and the potential of ensifentrine to become an important
therapy in a broad population of COPD patients, the potential of
ensifentrine in the treatment of cystic fibrosis, non-cystic
fibrosis bronchiectasis, asthma and other respiratory diseases, and
the potential of the DPI and pMDI formulations of ensifentrine.
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; 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, third-party service providers
and licensees; our inability to realize the anticipated benefits
under licenses granted by us to third parties to develop and
commercialize ensifentrine, 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; lawsuits related to patents covering ensifentrine and
the potential for our patents to be found invalid or unenforceable;
lawsuits related to our licensing of patents and know-how with
third parties for the development and commercialization of
ensifentrine; changes in our tax rates, unavailability of certain
tax credits or reliefs or exposure to additional tax liabilities or
assessments could affect our profitability, and audits by tax
authorities could result in additional tax payments for prior
periods; and our vulnerability to natural disasters, global
economic factors, geo-political actions and unexpected events,
including health epidemics or pandemics. These and other important
factors under the caption “Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2023, as updated in our
Quarterly Reports on Form 10-Q 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.
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