Verona Pharma plc Verona Pharma Initiates Phase 2 Clinical Trial To Evaluate Dry Powder Inhaler Formulation Of Rpl554 For Mai...
December 17 2018 - 1:00AM
UK Regulatory
TIDMVRP
Delivery via inhalers could dramatically expand clinical utility and
commercial opportunity for RPL554
LONDON, Dec. 17, 2018 (GLOBE NEWSWIRE) -- 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 the initiation of a Phase 2
clinical trial to evaluate the pharmacokinetic ("PK") profile, efficacy
and safety of a dry powder inhaler ("DPI") formulation of RPL554 in
patients with moderate to severe chronic obstructive pulmonary disease
("COPD").
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 designed to have bronchodilator as well as
anti-inflammatory properties, and is currently in development for the
maintenance treatment of COPD, cystic fibrosis ("CF") and asthma.
This randomized, double-blind, placebo-controlled, two-part study with
the DPI formulation, being conducted at one site in the US, will enrol
approximately 36 patients with COPD. The primary objective of the first
part of the study is to evaluate the PK profile following a single dose
of RPL554 when administered by DPI. Secondary objectives include
evaluating the safety, tolerability and the bronchodilator effect of a
single dose of RPL554 administered by DPI. The second part of the study,
conducted as a multiple dose crossover study, will evaluate the
bronchodilator effect of repeat doses of RPL554 administered by DPI in
terms of peak forced expiratory volume in one second ("FEV(1) ").
Secondary objectives of this part of the study include evaluating the
safety, tolerability and bronchodilator effect of repeat doses of RPL554
administered by DPI, as well as the PK profile, onset of action, and the
amount of rescue medication use during treatment periods. Data from the
single dose part of the study are expected during the first half of
2019.
RPL554 has been studied via the nebulized route of administration in 12
completed clinical trials involving more than 730 subjects. Verona
Pharma has demonstrated in previous Phase 2 trials in patients with COPD
that nebulized RPL554 significantly improves lung function, including
improved peak FEV(1) , reduced lung hyperinflation, and faster
onset-of-action, when added to some of the most commonly used COPD
treatments, including tiotropium, ipratropium, and albuterol. The
studies also showed that RPL554 is well tolerated.
"Positive results using inhaler formulations could dramatically expand
the clinical utility and commercial opportunity for RPL554 in the
maintenance treatment of COPD and potentially broaden its use for other
respiratory indications, such as asthma," said Jan-Anders Karlsson, PhD,
CEO of Verona Pharma. "With an estimated 5.4 million people using
inhalers for the maintenance treatment of COPD in the US alone, and
another one million patients using nebulized formulations, we believe it
is important to understand how RPL554 works via these different delivery
platforms in order to fully realize and leverage its clinical potential
for patients with respiratory diseases.(1) We look forward to building
upon the positive results that have been garnered to date utilizing the
nebulized formulation of RPL554."
In addition, Verona Pharma is currently conducting a Phase 2 clinical
trial to evaluate nebulized RPL554 as an add-on treatment to dual
LAMA/LABA therapy and triple LAMA/LABA/ICS therapy and also plans to
evaluate RPL554 as a metered-dose inhaler ("MDI") formulation as part of
a comprehensive clinical program to fully demonstrate the clinical
utility of RPL554 in improving the standard of care for COPD.
About Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease ("COPD") is a progressive and
life-threatening respiratory disease for which there is no cure.(2)
Although COPD is thought to be underdiagnosed, globally, around 384
million people suffer from the disease.(3) 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.(2,[4]) The condition damages the airways and the
lungs, leading to persistent symptoms of 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.(2) Many
experience acute periods of worsening symptoms called 'exacerbations',
often leading to emergency department visits or hospital admissions and
are also associated with high mortality.(5) In the United States 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.(6) About
30-40% of moderate to severe COPD patients on triple inhaled therapy
(ICS/LAMA/LABA) remain uncontrolled and continue to experience airway
obstruction (breathing difficulties), COPD symptoms and
exacerbations.(7,8) There is an urgent need for drugs with novel
mechanisms of action that can be used by these patients in addition to
current therapies.
About Verona Pharma plc and RPL554
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, 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
previous clinical trials, RPL554 has been observed to result in
bronchodilator effects when used alone or as an add-on treatment to
other COPD bronchodilators. It has shown clinically meaningful and
statistically significant improvements in lung function when
administered in addition to frequently used short- and long-acting
bronchodilators, such as tiotropium (Spiriva(R) ), compared with such
bronchodilators administered as a single agent. RPL554 improved FEV(1)
over four weeks in patients with moderate-to-severe COPD when compared
to placebo and improved COPD symptoms and Quality of Life in a Phase 2b
multicenter European study performed in 403 patients. In addition,
RPL554 has shown anti-inflammatory effects in a standard challenge study
with COPD-like inflammation in human subjects. RPL554 has been well
tolerated in these studies and has a favorable safety and tolerability
profile, having been administered to more than 730 subjects in 12
clinical trials. Verona Pharma is developing RPL554 for the treatment of
chronic obstructive pulmonary disease ("COPD"), cystic fibrosis ("CF"),
and potentially asthma.
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, statements regarding the design of the
Phase 2 clinical trial of RPL554, the timing of availability of top-line
data for the Phase 2 clinical trial, the importance of the Phase 2
clinical trial to our development plans for RPL554, the potential of
RPL554 as a promising first-in-class treatment option for COPD, and the
value of the data and insights that may be gathered from the Phase 2b
clinical trial.
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 Tel: +44 (0) 20 7710 7600
and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison
FTI Consulting (UK Media and Investor enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.com
ICR, Inc. (US Media and Investor enquiries)
Darcie Robinson Tel: +1 203-919-7905
Darcie.Robinson@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
(1) Q2 2017 Verona US COPD physician survey research, Trends in COPD:
Morbidity and Mortality, American Lung Association, 2013, Make et al,
Intl. Journal of COPD, 2012
(2) World Health Organization. Chronic Obstructive Pulmonary Disease.
https://www.globenewswire.com/Tracker?data=vq1FtPYtscLYW1G7wJC9E_xbaHNrgGr9CefPfAFZ3qxFbAgOawCi-3hjpJJ1htWH7Ksufu1lZOtdOCmbGkLTj7NBsMGXvAgol9-rR-mUhEa9D3ABpWxSUCvNkDMHRpf-gk-HOrHctXuY-snelrzj6GuHUAo_9xDby-C2KyXpyoo=
http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed September
2017.
(3) 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.
(4) World Health Organization. Burden of COPD.
https://www.globenewswire.com/Tracker?data=vq1FtPYtscLYW1G7wJC9E3LYvvQ6eX_IgUqKliuB9HJfscRa87uN8m7jpX-PmLkeFWAmQIAZZ7SfErLQ9lHEsOi6lIwNRMLIigIx6_q1QoA_QzejXpMA7vGOhw9SC2EM_-G-hsBKb3b0Yjck1-d-CuNjA4OZ8J1Mb6N7M8c2bmk=
http://www.who.int/respiratory/copd/burden/en/. Accessed September 2017.
(5) COPD Foundations. Characteristics of COPD Patients Using United
States Emergency Care or Hospitalization.
https://www.globenewswire.com/Tracker?data=DXemKVOFpCLvJo-RZH9GS2_RjUAEoVMNUecBQ6ibtKUWrkdKBFJiFbECx9K3UPnR7MuNYgPoba_sFjKMpfkACKoIUMzuT_ca-d4cW5BPjekbu4VXppKF6D-6NjwKX7Ens9HoQj8wwxMscGIDTwvetH7iWa0cuif6nN6NwqXBdm2EiN_WVITUxBw7-5WEi0SLt174WyTeYgRBAakDOIl1cAaihJDv5QOGfzwr6elwo9gKs2EcbGtbz05OuNspEFyUrmptHpLZQ1PCb1telg0CHVj6at96wq8XNRHJBaq83-oMg6TMK-TBQzOvCQs4YyQg1dygBmmmiu8eUS60kA852zbqjvnLQdQ-ntLzmhXIdvMJLeiRvquXQ8qf1_WQnxfxMckRj3TePNWnuVj5u7l5Gw==
https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization.
Accessed September 2017.
(6) Centers for Disease Control. Increase Expected in Medical Costs for
COPD.
https://www.globenewswire.com/Tracker?data=DXemKVOFpCLvJo-RZH9GS52eqiC9InG4gZEFR0JXV_RW1qGpxi6jdqV4MXsZp1kXV5GDQQT31sDjs4ttSHUbdRTLgV-k2Xv-44oDXnSKd9mmJozF3-ExZ5fk73ssyVSgClUWIomHYGLvfC0N-z9UJg==
https://www.cdc.gov/features/ds-copd-costs/. Accessed September 2017.
7 Mullerova H., et al., Characterization of COPD Patients Treated With
Inhaled Triple Therapy Containing Inhaled Corticosteroid [ICS],
Long-Acting Beta2-Agonists [LABA], and Long-Acting Muscarinic
Antagonists [LAMA] in the UK, American Journal of Respiratory and
Critical Care Medicine 2017;195:A4986
8 Vestbo J, et al., Single inhaler extrafine triple therapy versus
long-acting muscarinic antagonist therapy for chronic obstructive
pulmonary disease (TRINTY); a double-blind, parallel group, randomised
controlled trial, The Lancet, Vol 389, p. 1919-1929; May 13, 2017.
(END) Dow Jones Newswires
December 17, 2018 02:00 ET (07:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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