Verona Pharma plc Verona Pharma Announces Publication Of Key Phase 2b Copd Data In Respiratory Research

 
TIDMVRP 
 
 
   Paper demonstrates ensifentrine's potential in improving lung function 
and quality of life symptoms 
 
   LONDON, Feb. 14, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical 
company focused on respiratory diseases, announces publication of Phase 
2b clinical trial results for ensifentrine as a maintenance treatment 
for chronic obstructive pulmonary disease ("COPD") in the leading peer 
reviewed journal, Respiratory Research. The study met its primary 
endpoint demonstrating that ensifentrine produced clinically and 
statistically significant improvements in lung function at all doses. 
Also, clinically relevant secondary endpoints were met including 
significant progressive improvements in COPD symptoms. 
 
   The paper, entitled "A dose-ranging study of the inhaled dual 
phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD," was published 
on-line 
https://www.globenewswire.com/Tracker?data=Rbn3Rm3gG7v633k0A40MxHsnPiqyFordvKJFku0JEc_xeLbl3rs4pa-R85jy1fJawUqlhLVuFU4Lp68_iuuP601fcGcOZHR73F9Ig_QhyLSEAcHxZZ_ASRQ1QDXSyqX06EruyR71hT09ojZK1q-04g== 
here. Results from the 4-week 400-patient study were first reported in 
March 2018 and further positive analysis was presented in May 2019 at 
the American Thoracic Society International Conference. 
 
   Lead development candidate ensifentrine is a first-in-class, inhaled, 
dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been 
shown to act both as an anti-inflammatory and bronchodilator agent in a 
single compound. In January 2020, Verona Pharma reported positive 
top-line results from a second 4-week 400-patient Phase 2b study with 
nebulized ensifentrine added on to inhaled tiotropium (Spiriva(R) 
Respimat(R) ) therapy in symptomatic COPD patients. 
 
   Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory 
Medicine, Medicines Evaluation Unit, University of Manchester, and Lead 
Investigator in the study commented: "These encouraging data published 
in Respiratory Research, combined with ensifentrine's unique mode of 
action, support its potential as a novel therapy to meet the high unmet 
medical need in COPD. The improvements in patients' symptoms, including 
breathlessness, are particularly noteworthy." 
 
   David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: 
"The compelling data from our two successful Phase 2b studies in COPD, 
one in patients with no background therapy and the second in symptomatic 
patients already on maintenance therapy, are further evidence of 
ensifentrine's promising therapeutic potential. We look forward to 
discussing these results, along with positive data from previous 
clinical studies, in an End-of-Phase 2 meeting with the FDA, anticipated 
for 2Q 2020. We expect this meeting to provide key guidance with respect 
to the design of our Phase 3 program." 
 
   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 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 be the first therapy for the 
treatment of respiratory diseases that combines bronchodilator and 
anti-inflammatory activities in one compound. Verona Pharma is currently 
in Phase 2 development with three formulations of ensifentrine for the 
treatment of COPD: 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 
https://www.globenewswire.com/Tracker?data=98IQ30Z0hjYvSc5fVjk8n1JylYQShns6HtZ0DfTof0Jtd0O0fnfFm7c1vWKggJ9OhwZGlpeecCB2H8Rdap7KxFs-ktJZf3YHM6qr1UmKVfw= 
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 be a first-in-class phosphodiesterase 
3 and 4 inhibitor, and to be the first therapy for the treatment of 
respiratory diseases to combine bronchodilator and anti-inflammatory 
activities in one compound, the potential for ensifentrine to have a 
significant impact on the treatment of COPD, estimates of medical costs 
for COPD and the number of symptomatic COPD patients, 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 future growth and ability to compete depends on retaining 
our key personnel and recruiting additional qualified personnel; 
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; and lawsuits related to patents covering 
ensifentrine 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 March 19, 2019, 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 
David Moskowitz, VP Capital Markets Strategy & Investor 
 Relations (Investor enquiries) 
 Victoria Stewart, Director of Communications (Media 
 Enquiries) 
 
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

February 14, 2020 02:00 ET (07:00 GMT)

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