Verona Pharma To Present Expanded Dataset From Rpl554 Phase 2b Clinical Trial In Copd At European Respiratory Society Interna...
September 12 2018 - 2:00AM
UK Regulatory
TIDMVRP
Late breaking oral presentation will provide additional detail around
previously reported top-line results
LONDON, Sept. 12, 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 it will present an expanded dataset
from its Phase 2b study evaluating RPL554 as a maintenance treatment for
chronic obstructive pulmonary disease ("COPD") in an oral presentation
at the European Respiratory Society International Congress ("ERS") in
Paris from September 15-19, 2018.
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 and for the treatment of cystic fibrosis
("CF").
Details of the Company's oral presentation are listed below and the
abstract is available to the public online via the European Respiratory
Society International Congress website
https://www.globenewswire.com/Tracker?data=goNMxeHh5n9eyIedZYnlFlMQ_nPZq5LIf1w52nRfmBkuYwE8-oAkGitk6Px10uy9O1TlCWNmpxocgl3rLD66kaBcEdEaC6zUWmX_FvOoerurhlmQJ3zYiGp57olyZY_p
here.
Oral Presentation (Late Breaking Abstract OA1940): RPL554, A
First-In-Class Dual PDE3/4 Inhibitor, Causes Significant Bronchodilation
and Symptom Relief; a Phase 2b COPD Study
Session 220: Novel Drug Targets for Asthma and COPD
Date and Time: Monday September 17, 2018 at 8:30 AM CEST / 7:30 AM BST /
2:30 AM ET
Location: Paris Expo Porte de Versailles; Room 7.3M
Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory
Medicine, Medicines Evaluation Unit, University of Manchester, will
present data from the late breaking abstract, expanding on top-line
results announced by the Company on
https://www.globenewswire.com/Tracker?data=ak_BfXpAmufuslsZVHhvtEA78zqmcjusAGXlWhRRy0IaMr2tFUlFedy3igJvi9SpWq6rye9iv6E23tKHreBVh9nZIloenaedjQ78uvVIJHJibedKIN2-fkto7fAx_jr4NuQbYYHh0HXvC22ViY_ZEwFy5zfkHj2qo6IOVvkSn3oumhu-3WF6Y92Vh4PITkwcl-9RbU_ZOw03IMFVFVrVO1ZCpqiIBcOaQuKvpSWpiObb6yo-PKZFwYfBmifWrlz9jYE1n-ogbt8cFQk2U1PoNOMCemItf8kRCGZp8hy5Lxk=
March 26, 2018. Dr. Singh will also provide further context around the
clinical significance of these results and potential for RPL554 therapy
in both the stand-alone and add-on to standard of care settings for
patients with this progressive and debilitating disease, where there
remains a high unmet medical need.
Verona Pharma has demonstrated in previous Phase 2 trials that RPL554
significantly improves lung function, including improved peak lung
function, reduced lung hyperinflation, and faster onset-of-action, when
added to some of the most commonly used COPD treatments, including
tiotropium, ipratropium, and albuterol. Verona Pharma is currently
conducting a Phase 2 clinical trial to evaluate RPL554 as an add-on
treatment to dual LAMA/LABA therapy and triple LAMA/LABA/ICS therapy, as
part of a comprehensive clinical program to fully demonstrate the
clinical utility of RPL554 in improving the standard of care for COPD.
These data will also support the planning of the RPL554 Phase 3 program.
About COPD
Chronic obstructive pulmonary disease ("COPD") is a progressive and
life-threatening respiratory disease for which there is no cure.(1)
Although COPD is thought to be underdiagnosed, globally, around 384
million people suffer from the disease.(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]) 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.(1) 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.(4) 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.(5) 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.(6) 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 value of trial
results presented at ERS 2018, RPL554 as a new complementary treatment
for patients with COPD, projected annual medical costs related to COPD,
the future clinical development and positioning of RPL554, 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 Annual Report on Form 20-F filed
with the Securities and Exchange Commission ("SEC") on February 27, 2018
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)
James Heins Tel: +1 203-682-8251
James.Heins@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
(1) World Health Organization. Chronic Obstructive Pulmonary Disease.
https://www.globenewswire.com/Tracker?data=AT4NBGUPUz_vkGBZqYBmZTLmPVZtvjJmYNn49G475pGQR13MbTDg6LiaIZGl1I8ztEMOVyuDIDjxFiG-SUTqEW780ndvA2G812pEpwMz2_thOBCiaC2CPecp5Mn_jCN1FSlLmkpTkfPgHaHqXpTjfOM43B2XYwpJlt2IOyAXXkQ=
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.
https://www.globenewswire.com/Tracker?data=AT4NBGUPUz_vkGBZqYBmZXBGeODoeylSRtHvbClwo1WpBl9_ItpxZ9T2OmmY9UC2Og9o1rV1b3txCIHb2_FcSiGZRN2bzIpY5D3cZEw7NByvLww_VgmQPgt2xV7IJTdBBdYe7Or3Tz_U-EEF7XMBChEWxNNZTvgW6k3ZuepQ_G4=
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://www.globenewswire.com/Tracker?data=8X-CbhyGAMxSwrEHrvAo2RAvZgLpOx2vF_vJH1ILLwUUHUB4fzlAmRMR7kk3P-Ig7P3VM_9p2u5IVeDp-C4SqyzgoH5uvv_DCt0zfNXA350USVOf5YReOXMSKZLbGpH4w_oc14NSaakHaTN1JaUF8ueioOj3ouFk9O0JYur0cgvOGEaemoZWZSA0XIxtLMdNpBCwi1UZyVFzfD3iKIWa26xeCaeiSLWLSXs_KVqmwLqcuVI30QdU4_Sj6ZxNTmJY4UCix6wB9FqqEfdE6ME61L9yFiAm0cLfANnegf5q4dQ79OOmjmwEXxUBrS7SidZ4GgzKfEFPst6vVWFgxr5HMTSC_Lht4nymPsKa6auoDi12RUFYvmwpEJQ7xFqvzJVoBXoLvwe7egEtbe0hC5K8Kg==
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.globenewswire.com/Tracker?data=8X-CbhyGAMxSwrEHrvAo2aNc8EehJP9E-xqRvMSXHqmxLn1olFywb_LWkZ4Ve648UqxjL2DbwKQ1E7aKYs1zzljL2LFboXg1sz33FS-1cou3Jh2LZdeLvAQeXF3Jc73S-hQuK0tkKDZLEqpOfm8u4A==
https://www.cdc.gov/features/ds-copd-costs/. Accessed September 2017.
(6) 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
(6) 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
September 12, 2018 02:00 ET (06:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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