Verona Pharma plc Verona Pharma Completes Enrollment In Phase 2b Clinical Trial With Nebulized Ensifentrine In Moderate-to-se...
October 17 2019 - 2:00AM
UK Regulatory
TIDMVRP
Results to Inform Development Plan and Dose Selection for Phase 3
LONDON, Oct. 17, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP)
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on
respiratory diseases, announces that it has randomized the last patient
in its Phase 2b dose-ranging study evaluating the effect of nebulized
ensifentrine as an add-on to treatment with a long acting bronchodilator
in patients with moderate-to-severe chronic obstructive pulmonary
disease ("COPD").
Ensifentrine has the potential to be the first novel class of
bronchodilator in over 40 years, and the first therapy for the treatment
of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one compound. The addition of nebulized
ensifentrine to symptomatic COPD patients already treated with
standard-of-care medicines represents a significant market opportunity.
Highlights:
-- Enrollment completed on schedule with data expected around year end 2019
-- Preparations underway for End-of-Phase 2 meeting with the U.S. FDA
expected in the first half of 2020
-- Commencement of Phase 3 trials expected in 2020
"We remain on track to deliver data from this important Phase 2b
clinical trial in patients with moderate-to-severe COPD around year end
2019," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We expect
this second Phase 2 study with nebulized ensifentrine in COPD to help
inform our planned Phase 3 clinical development program, which we expect
to start in 2020. Millions of COPD patients urgently need better
treatments as they remain symptomatic despite maximum treatment with
currently available therapies. We believe ensifentrine, with its unique
mode of action and clinical profile, will have an important role in
treating these patients."
This four-week randomized, double-blind, placebo-controlled dose-ranging
Phase 2b trial enrolled a total of 416 patients with moderate-to-severe
symptomatic COPD at 46 sites in the U.S. The trial is designed to
evaluate the safety and efficacy of nebulized ensifentrine as an add-on
to inhaled tiotropium, a long acting anti-muscarinic ("LAMA") commonly
used to treat patients with COPD.
Patients will receive nebulized ensifentrine at four dose levels: 0.375
mg, 0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for four weeks.
The trial's primary endpoint is improvement in lung function with
ensifentrine after four weeks of treatment, as measured by peak forced
expiratory volume in one second ("FEV(1) "), a standard measure of lung
function. Key additional endpoints include other lung function measures,
as well as measurements of symptoms associated with COPD and quality of
life outcomes. For further information on this clinical trial, please
visit
https://www.globenewswire.com/Tracker?data=ctF4xP9ZDsOu5M7etUH5FXGnUM6vQO0N1uhz0ISzqP5wA60S19oXTEfw_fa0eKuDaymIilXyFz3YBgbUl4kwpK2AqDxCVmqmSHBiA1VgcToFwBT4KG3KRoMKZlNhxmMpp-URgB2LbvcVPgRNP489SHkmqijbVMBpW7kphwDyzra90jXm91ulr_2w11RP8J6N
ClinicalTrials.gov, NCT03937479.
Verona Pharma is also developing two additional formulations of
ensifentrine, a dry powder inhaler ("DPI") and a pressurized
metered-dose inhaler ("pMDI"). In July 2019, the company reported
positive data from its Phase 2 trial with the DPI formulation, which
demonstrated statistically significant and clinically meaningful
dose-dependent improvements in lung function in moderate-to-severe COPD.
Verona Pharma is conducting a Phase 2 trial with the pMDI formulation
and expects to report data from the first part of the trial in the
fourth quarter of 2019, with final data expected in the first half of
2020.
About COPD
COPD is a progressive and life-threatening respiratory disease without a
cure. The World Health Organization estimates that it will become the
third leading cause of death worldwide by 2030. 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. In the United States
alone, the total annual medical costs related to COPD are projected to
rise to $49 billion in 2020. About 1.2 million US COPD patients on
dual/triple inhaled therapy (LAMA/LABA +/- ICS) remain uncontrolled,
experiencing symptoms that impair quality of life. These patients
urgently need better treatments.
About Ensifentrine
Nebulized ensifentrine (RPL554) has shown significant and clinically
meaningful improvements in both lung function and COPD symptoms,
including breathlessness, in Verona Pharma's prior Phase 2 clinical
studies in patients with moderate-to-severe COPD. In addition, nebulized
ensifentrine showed further improved lung function and reduced lung
volumes in 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 800 people to date.
About Verona Pharma plc
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. Verona
Pharma's product candidate, ensifentrine, is a first-in-class, inhaled,
dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been
shown to act as both a bronchodilator and an anti-inflammatory agent in
a single compound. Three formulations of ensifentrine are under
development for the treatment COPD: nebulized ensifentrine is currently
in Phase 2b clinical development for the maintenance treatment of COPD
and is planned to enter Phase 3 trials for this indication in 2020; a
dry powder inhaler ("DPI") formulation reported positive Phase 2 data in
August 2019; a pressurized metered-dose inhaler ("pMDI") formulation
expects to report Phase 2 single dose data in the fourth quarter of
2019, with final data expected in the first half of 2020. Verona Pharma
may also develop ensifentrine for the treatment of cystic fibrosis and
asthma.
For more information, please visit 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,
including the design of clinical trials, the progress and timing of
clinical trials and data and meetings with the U.S. FDA, estimates of
medical costs for COPD and its status as a leading cause of death
worldwide, ensifentrine as the first novel class of bronchodilator in
over 40 years and the first to combine bronchodilator and
anti-inflammatory activities and a first-in-class phosphodiesterase 3
and 4 inhibitor, the market opportunity for ensifentrine, the Phase 2b
clinical trial with nebulized ensifentrine informing the Phase 3
clinical development program, the impact of ensifentrine in treating
COPD patients, and plans to develop ensifentrine for the treatment of
cystic fibrosis and asthma.
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 Phase 2b trial; 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; material differences between our "top-line" data and final
data; our reliance on third parties, including 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. These and other
important factors under the caption "Risk Factors" in our Annual Report
on Form 20-F filed with the Securities and Exchange Commission ("SEC")
on March 19, 2019, 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.
For further information, please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer Tel: +44 (0)20 3283 4200
(Nominated Adviser and UK Broker)
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate
Finance)
Mia Gardner (Corporate Broking)
Optimum Strategic Communications Tel: +44 (0)20 950 9144
(European Media and Investor Enquiries) verona@optimumcomms.com
Mary Clark / Eva Haas / Hollie Vile
Argot Partners Tel: +1 212-600-1902
(US Investor enquiries) verona@argotpartners.com
Stephanie Marks
(END) Dow Jones Newswires
October 17, 2019 02:00 ET (06:00 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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