Verona Pharma To Present Expanded Dataset From Rpl554 Phase 2b Clinical Trial In Copd At European Respiratory Society Interna...

 
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: [phone] 
Jan-Anders Karlsson, Chief Executive Officer       [e-mail] 
 
Stifel Nicolaus Europe Limited (Nominated Adviser  Tel: [phone] 
 and UK Broker) 
Stewart Wallace / Jonathan Senior / Ben Maddison 
 
FTI Consulting (UK Media and Investor enquiries)   Tel: [phone] 

Simon Conway / Natalie Garland-Collins             [e-mail] 
 
ICR, Inc. (US Media and Investor enquiries) 
James Heins                                        Tel: [phone] 
                                                    [e-mail] 
Stephanie Carrington                               Tel. [phone] 
                                                    [e-mail] 
 
 
 
   (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)

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