Verona Pharma plc (AIM:VRP) (NASDAQ:VRNA) (“Verona Pharma”), a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapies for respiratory diseases,
announces today top-line results from its clinical pharmacokinetic
(PK) trial in the United States demonstrating that inhaled RPL554
is an appropriate form of administration for patients with chronic
obstructive pulmonary disease (COPD) and other respiratory
disorders.
With any inhaled or nebulized medication, a
portion of the substance is deposited in the mouth and then
swallowed by the patient. These results show that in the study
subjects only 10.4 percent of the inhaled dose entered the
bloodstream via the gastrointestinal tract. The low oral
bioavailability of nebulized RPL554, as demonstrated in the study,
is consistent with optimal inhaled delivery of medications for the
treatment of COPD and asthma. Therefore, the results from this
study confirm that inhaled RPL554 is an appropriate form of
administration for patients.
This complete block two-way crossover trial
evaluated a single dose of RPL554 in 12 healthy volunteers to
determine the process of bodily absorption, distribution,
metabolism and excretion of this novel therapy, including the
swallowed portion of the nebulized dose. The trial was conducted
under an Investigational New Drug application accepted by the U.S.
Food and Drug Administration in June 2017, and Verona Pharma is
reporting top-line results earlier than expected.
Highlights
• Primary outcome measures:
- 10.4 percent of nebulized RPL554 reached the bloodstream via
the gastrointestinal tract demonstrating suitability for inhaled
administration.
- 11.9 hour half-life in blood is consistent with earlier data
and supports twice-daily dosing of RPL554.
• Secondary outcome measures:
- Low oral bioavailability and blood levels of RPL554, as a
result of swallowed medication, suggest limited contribution to
systemic effects of inhaled medication in the lungs.
- RPL554 was well tolerated by all subjects without any evidence
of safety concerns.
“These data demonstrate that inhalation of
RPL554 is an appropriate route of administration for people with
COPD and other respiratory diseases. The low oral bioavailability
seen in this PK trial reinforces that the swallowed portion of the
medication contributes very little to the effects of RPL554. The
inhaled portion provides novel bronchodilator and anti-inflammatory
effects, and has limited systemic exposure,” said Jan-Anders
Karlsson, PhD, CEO of Verona Pharma. “We believe that our ability
to consistently deliver higher doses of RPL554 directly to the
lungs, while at the same time having only low levels in the
bloodstream, is consistent with a promising therapeutic effect, and
we continue to see good tolerability of the compound across our
clinical trials.”
RPL554 is a first-in-class, inhaled, dual
inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have
anti-inflammatory as well as bronchodilator properties, and is
currently in development for the maintenance treatment of COPD
patients and for the treatment of patients with cystic
fibrosis.
In previous clinical trials, RPL554 has been
observed to result in bronchodilatory effects when used alone or in
combination with other COPD bronchodilators. These trials have
shown clinically meaningful and statistically significant
improvements in lung function when RPL554 is added to two commonly
used bronchodilators, as compared to the improvements in lung
function when either bronchodilator is administered as a single
agent. RPL554 has also shown anti-inflammatory effects in a
standard challenge study with COPD-like inflammation in human
subjects. In these studies, RPL554 has been well tolerated.
About COPD
Chronic obstructive pulmonary disease (COPD) is
a progressive and life-threatening respiratory disease for which
there is no cure.1 The condition damages the airways and the lungs,
leading to persistent breathlessness, impacting a person’s daily
life and their ability to perform simple activities such as walking
a short flight of stairs or carrying a suitcase.1 Although COPD is
thought to be underdiagnosed, globally, around 384 million people
suffer from the disease.1,[2] This number, according to the World
Health Organization (WHO), is likely to increase in coming years,
with estimates that COPD will become the third leading cause of
death worldwide by 2030.1,[3] Current COPD therapies focus on
reducing and controlling symptoms. Yet, despite the wide
availability of these treatments, many patients continue to suffer
acute periods of worsening symptoms known as exacerbations. These
exacerbations often lead to emergency department visits or hospital
admissions, and are also associated with high mortality.4 In the
U.S. alone, the 2010 total annual medical costs related to COPD
were estimated to be $32 billion, and are projected to rise to $49
billion in 2020.5
About Verona Pharma plc
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapeutics for the treatment of respiratory diseases
with significant unmet medical needs. Verona Pharma's product
candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of
the enzymes phosphodiesterase 3 and 4 that acts as both a
bronchodilator and an anti-inflammatory agent in a single compound.
In clinical trials, treatment with RPL554 has been observed to
result in statistically significant improvements in lung function
as compared to placebo and has shown clinically meaningful and
statistically significant improvements in lung function when added
to two commonly used bronchodilators as compared to either
bronchodilator administered as a single agent. Verona Pharma is
developing RPL554 for the treatment of chronic obstructive
pulmonary disease (COPD), cystic fibrosis, and potentially
asthma.
Forward-Looking StatementsThis
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 regarding delivery of
higher doses of RPL554 to the lungs having a promising therapeutic
effect, estimates that COPD will be the third leading cause of
death worldwide by 2030, and the treatment potential for
RPL554.
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 RPL554, 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 RPL554, 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 RPL554, which could adversely affect our ability to
develop or commercialize RPL554; potential delays in enrolling
patients, which could adversely affect our research and development
efforts; we may not be successful in developing RPL554 for multiple
indications; our ability to obtain approval for and commercialize
RPL554 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 RPL554;
and lawsuits related to patents covering RPL554 and the potential
for our patents to be found invalid or unenforceable. These and
other important factors under the caption “Risk Factors” in our
final prospectus filed with the Securities and Exchange Commission
(“SEC”) on April 28, 2017 relating to our Registration Statement on
Form F-1, 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 |
|
|
|
Stifel Nicolaus Europe Limited (Nominated Adviser and UK
Broker) |
|
Tel:
+44 (0) 20 7710 7600 |
Stewart Wallace / Jonathan Senior / Ben Maddison |
|
SNELVeronaPharma@stifel.com |
|
|
|
FTI
Consulting (UK Media and Investor enquiries) |
|
Tel:
+44 (0)20 3727 1000 |
Simon
Conway / Stephanie Cuthbert / Natalie Garland-Collins |
|
veronapharma@fticonsulting.com |
|
|
|
ICR,
Inc. (US Media and Investor enquiries) |
|
|
James
Heins |
|
Tel:
+1 203-682-8251James.Heins@icrinc.com |
Stephanie Carrington |
|
Tel.
+1 646-277-1282Stephanie.Carrington@icrinc.com |
____________________________1 World Health Organization. Chronic
Obstructive Pulmonary Disease.
http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed
September 2017.2 Adeloye D, Chua S, et al. Global and regional
estimates of COPD prevalence: Systematic review and meta–analysis.
J Glob Health 2015; 5(2): 020415.3 World Health
Organization. Burden of COPD.
http://www.who.int/respiratory/copd/burden/en/. Accessed September
2017.4 COPD Foundations. Characteristics of COPD Patients Using
United States Emergency Care or Hospitalization.
https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization.
Accessed September 2017.5 Center for Disease Control. Increase
Expected in Medical Costs for COPD.
https://www.cdc.gov/features/ds-copd-costs/. Accessed September
2017.
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