Verona Pharma plc Verona Pharma Completes Enrollment In Pilot Study Of Pmdi Ensifentrine In U.S. Patients Hospitalized With C...
January 14 2021 - 2:00AM
UK Regulatory
TIDMVRP
Top-line results expected in 2Q 2021
LONDON and RALEIGH, N.C., Jan. 14, 2021 (GLOBE NEWSWIRE) -- 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:
Verona Pharma plc Tel: +44 (0)20 3283 4200
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Victoria Stewart, Director of Communications info@veronapharma.com
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Argot Partners Tel: +1 212-600-1902
(US Investor Enquiries) verona@argotpartners.com
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Kimberly Minarovich / Michael Barron
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Optimum Strategic Communications Tel: +44 (0)203 950 9144
(International Media and European Investor Enquiries) verona@optimumcomms.com
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Mary Clark / Eva Haas / Shabnam Bashir
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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.
(END) Dow Jones Newswires
January 14, 2021 02:00 ET (07:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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