Verona Pharma plc Verona Pharma Reports Positive Efficacy And Safety Data With Single Dose Pmdi Formulation Of Ensifentrine I...
March 31 2020 - 2:00AM
UK Regulatory
TIDMVRP
Statistically significant and clinically meaningful improvements in lung
function
Ensifentrine has now demonstrated positive efficacy and safety in COPD
patients via three widely used inhalation modes: nebulizer, DPI and pMDI
Initiation of multiple dose part of pMDI trial postponed due to the
COVID-19 situation
LONDON, March 30, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP)
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical
company focused on respiratory diseases, announces positive efficacy and
safety data with a single dose of pressurized metered-dose inhaler
("pMDI") formulation of ensifentrine in a Phase 2 clinical trial in
patients with moderate to severe chronic obstructive pulmonary disease
("COPD"). Results from the single dose part of the study (Part A)
demonstrated a statistically significant and clinically meaningful
increase in lung function as measured by forced expiratory volume in one
second ("FEV(1) ")(1) compared to placebo.
In the first part of the trial, 40 patients with moderate to severe COPD
were randomized to receive a single dose of one out of five dosage
strengths of ensifentrine: 100 ug(2) , 300 ug, 1000 ug, 3000 ug, 6000 ug
or placebo. In these patients, we observed the following:
-- Improvements in peak FEV1 corrected for placebo demonstrated a general
dose response (ranging from 47 mL to 391 mL, p<0.05 for doses 300 ug and
above).
-- Improvements in average FEV1 over 4 hours corrected for placebo also
showed a general dose response (average FEV1 AUC(0-4hr)3: ranging from 69
mL to 345 mL, p<0.05 for doses 300 ug and above).
-- Improvements in average FEV1 over 12 hours corrected for placebo also
showed a dose response and demonstrated durability of effect over the
dosing interval (average FEV1 AUC(0-12hr4): ranging from 48 mL to 222 mL,
p<0.05 for doses 3000 ug and above), supporting twice-daily dosing.
-- Ensifentrine pMDI formulation was well tolerated at each dose with an
adverse event profile similar to placebo.
The positive data support initiation of the second, multiple dose, part
of the study (Part B), which will evaluate the pMDI formulation in this
patient population over 7 days of twice daily treatment. Verona Pharma
has decided to postpone the initiation of Part B due to concerns
regarding the safety of trial subjects, caregivers and medical staff
during the COVID-19 pandemic. We will continue to monitor this evolving
situation and will provide an updated timeline for the start of Part B
at a later date.
With these results and those observed in previous Phase 2 clinical
trials, ensifentrine has demonstrated statistically significant and
clinically meaningful improvements in lung function in COPD patients
when delivered via any of the three widely used inhaled modes: nebulizer,
dry powder inhaler ("DPI") and pMDI.
David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said:
"Across all three inhaled formulations, ensifentrine has demonstrated
statistically significant and clinically meaningful lung function
improvements and duration of action, supporting twice-daily dosing and a
safety profile similar to placebo. The results from the single dose part
of this pMDI study are very encouraging and essentially consistent with
data from Phase 2 clinical trials with nebulized and DPI formulations of
ensifentrine."
"Following the public health advice associated with COVID-19, we have
postponed enrollment of Part B of our pMDI Phase 2 trial in COPD. Our
planned End-of-Phase 2 meeting with the FDA is scheduled in the second
quarter of 2020, and the initiation of our Phase 3 trials of nebulized
ensifentrine is planned for later this year."
An estimated 5.5 million people in the US use inhaled delivery, pMDI or
DPI formulations delivered via handheld inhalers, for COPD maintenance
treatment. Delivery of a pMDI formulation of ensifentrine may create new
opportunities for using ensifentrine with existing inhaled medications.
US sales of inhaled COPD maintenance medication were approximately $9
billion in 2019.
(1) FEV(1) : Forced Expiratory Volume in one second, a standard measure
of lung function
(2) ug: microgram, or mcg
(3) FEV(1) AUC(0-4hr) : Area Under the Curve 0-4 hours calculated using
the trapezoidal rule, divided by the observation time (4 hours) to
report in mL, a measure of the aggregate effect over 4 hours
(4) FEV(1) AUC(0-12hr) : Area Under the Curve 0-12 hours calculated
using the trapezoidal rule, divided by the observation time (12 hours)
to report in mL, a measure of the aggregate effect over 12 hours
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF REGULATION (EU) NO 596/2014.
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, long-acting beta-agonist (LABA)/long-acting
muscarinic antagonist (LAMA) +/- inhaled corticosteroid (ICS) remain
uncontrolled, experiencing symptoms that impair quality of life. These
patients urgently need better treatments.
About Ensifentrine
Nebulized ensifentrine (RPL554) has shown statistically 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 1300 people 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 become the first therapy approved for
the treatment of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one compound. Verona Pharma is currently
evaluating three formulations of ensifentrine for the treatment of COPD
in Phase 2 clinical trials: nebulized, dry powder inhaler, and
pressurized metered-dose inhaler. Ensifentrine also 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, the
progress and timing of clinical trials, data and meetings with the FDA,
the potential for ensifentrine to become the first therapy approved for
the treatment of respiratory diseases to combine bronchodilator and
anti-inflammatory activities in one compound, the potential for
ensifentrine, if approved, to have a significant impact on the treatment
of COPD, estimates of market size for COPD, and the potential
application of ensifentrine for the treatment of 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 ability to retain our key personnel and recruit
additional qualified personnel, as well as the impact of our management
team transition; 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; 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 Annual Report
on Form 20-F filed with the Securities and Exchange Commission ("SEC")
on February 27, 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.
For further information, please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
David Zaccardelli, 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 / George Tzimas / Iqra Amin (Corporate
Finance)
Tom Salvesen (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 / Kimberly Minarovich / Michael
Barron
(END) Dow Jones Newswires
March 31, 2020 02:00 ET (06:00 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Verona Pharma (LSE:VRP)
Historical Stock Chart
From Apr 2024 to May 2024
Verona Pharma (LSE:VRP)
Historical Stock Chart
From May 2023 to May 2024