Verona Pharma to Present Additional Analysis of Phase 3 ENHANCE-1 Study in COPD at ERS International Congress 2023
06 Septiembre 2023 - 1:00AM
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the
“Company”), announces an oral presentation on an additional
analysis from its successful Phase 3 ENHANCE-1 study with
ensifentrine for the treatment of chronic obstructive pulmonary
disease (“COPD”) will be presented at the European Respiratory
Society (“ERS”) International Congress 2023. The abstract is
available to conference attendees on the ERS website and will be
published in an upcoming issue of the peer reviewed publication,
European Respiratory Journal.
The presentation will highlight additional
analyses of the ENHANCE-1 24-week exacerbation data which
demonstrated treatment with ensifentrine resulted in a substantial
decrease in the rate and risk of moderate COPD exacerbations as
well as moderate and severe COPD exacerbations. Furthermore, it
will highlight the impact of ensifentrine treatment on healthcare
resource utilization related to COPD including fewer physician’s
office visits, emergency department visits and hospitalizations
compared with placebo treatment.
Henrik Watz, MD, Respiratory Physician at The
Pulmonary Research Institute at LungenClinic Grosshansdorf,
Germany, commented: “This exciting analysis from the ENHANCE-1
study further demonstrates ensifentrine’s potential to become a
first-in-class bronchodilator and non-steroidal anti-inflammatory
therapy for COPD. The reduction in the rate and risk of
exacerbations is impressive and, combined with the data showing
substantial reductions in healthcare resource utilization, these
data support ensifentrine’s potential, if approved, to provide
meaningful benefits for COPD patients.”
Details of Verona Pharma’s presentation are
listed below and linked to the ERS website:
Oral presentation 2602: Inhaled
Ensifentrine, decreased healthcare research utilization and reduced
moderate exacerbation rate and risk in COPD over 24
weeksParticipant: Henrik Watz, MD, Pulmonary
Research Institute at LungenClinic Grosshansdorf, Airway Research
Center North, German Center for Lung Research, Grosshansdorf,
Germany.Session 269: New mechanisms and novel
insights into chronic obstructive pulmonary disease and chronic
cough
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 |
|
|
|
About Verona Pharma
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of chronic 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 non-steroidal
therapy for the treatment of respiratory diseases that combines
bronchodilator and anti-inflammatory activities in one molecule.
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 pooled analysis from ENHANCE-1 and ENHANCE-2. In
the second quarter of 2023, Verona Pharma submitted a New Drug
Application (“NDA”) to the US Food and Drug Administration (“FDA”)
for ensifentrine for the maintenance treatment of patients with
COPD. 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”).
Ensifentrine 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,
statements relating to the timing of the FDA’s decisions on the
acceptance and approval of the NDA for ensifentrine, or at any
other time, statements regarding the potential for ensifentrine to
be the first novel mechanism available for the treatment of COPD in
over 10 years, the first therapy for the treatment of respiratory
diseases to combine bronchodilator and non-steroidal
anti-inflammatory activities in one molecule, and the potential to
change the treatment paradigm for COPD patients, the potential of
ensifentrine in the treatment of cystic fibrosis, 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, 2022, as updated in our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
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.
Verona Pharma (NASDAQ:VRNA)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Verona Pharma (NASDAQ:VRNA)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024