Verona Pharma Completes Enrollment in Pilot Study of pMDI Ensifentrine in U.S. Patients Hospitalized with COVID-19
2021年1月14日 - 4:00PM
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on respiratory
diseases, announces it has completed enrollment (n=45) in its pilot
clinical study evaluating the efficacy and safety of ensifentrine
delivered via pressurized metered-dose inhaler (“pMDI”) formulation
in U.S. patients hospitalized with COVID-19.
David Zaccardelli, Pharm. D., President and CEO
of Verona Pharma, said: “Completing enrollment of the pilot study
in COVID-19 is an important milestone and we are on track to report
top-line results in the second quarter of 2021. We are pleased
vaccines are now approved for the prevention of COVID-19; however,
a significant unmet need remains for effective treatments for
symptomatic patients. We believe ensifentrine, with its novel
mechanism of action, could help to improve COVID-19 patient
outcomes.”
Ensifentrine is a first-in-class product
candidate with both bronchodilator and anti-inflammatory activities
in one compound. Clinical data from studies of ensifentrine in the
treatment of other respiratory diseases have shown ensifentrine
improved lung function, reduced inflammation in the lungs* and
reduced symptoms of cough and sputum production. Ensifentrine has
been well tolerated in clinical trials involving more than 1,300
people.
About the study
The randomized, double-blind, parallel group
pilot study will evaluate the efficacy and safety of pMDI
ensifentrine added on to standard of care treatment in patients
with COVID-19 compared to standard of care plus placebo.
- Patient
Population: 45 hospitalized patients with COVID-19. Single center
study at University of Alabama at Birmingham.
- Dose/Duration:
Patients randomized to receive 2 mg of pMDI ensifentrine or
placebo, twice-daily for up to 29 days or until discharge if this
occurs before 29 days. The clinical status of all patients will be
evaluated daily until discharge and at Day 29 and Day 60.
- Primary
Endpoint: Proportion of patients recovered from COVID-19 and no
longer hospitalized at Day 29.
- Secondary
Endpoints: Safety and tolerability, time to recovery, duration of
hospitalization, improvements in clinical status, supplemental
oxygen use, proportion of patients requiring mechanical ventilation
and mortality.
Further information about this study can be
found at www.clinicaltrials.gov, NCT04527471.
*Franciosi LG, et al., Lancet Respir Med
2013
For further information, please contact:
|
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Verona Pharma plc |
Tel: +44 (0)20 3283 4200 |
Victoria Stewart, Director of Communications |
info@veronapharma.com |
|
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Argot Partners(US Investor Enquiries) |
Tel: +1 212-600-1902verona@argotpartners.com |
Kimberly Minarovich / Michael Barron |
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|
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Optimum Strategic Communications(International
Media and European Investor Enquiries) |
Tel: +44 (0)203 950 9144verona@optimumcomms.com |
Mary Clark / Eva Haas / Shabnam Bashir |
|
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
being evaluated 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, including, but not limited to, the
development of ensifentrine and the progress and timing of clinical
trials and data, the goals and design of clinical trials, 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 effects in one compound, the potential of
ensifentrine to significantly benefit patients with COVID-19 and to
be safe and well tolerated in those patients, the potential of
ensifentrine to alleviate respiratory symptoms such as
breathlessness and cough and work against inflammation triggered by
viruses, the sufficiency of funds to supports its operations and
Phase 3 clinical program into 2023, and the potential of
ensifentrine in the treatment of COPD, 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
Registration Statement on Form F-1 filed with the SEC on August 17,
2020, our Report on Form 6-K filed with the SEC on November 24,
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.
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