Verona Pharma plc Verona Pharma To Present Phase 2 Data With Ensifentrine Dry Powder Inhaler Formulation In Copd At European ...

 
TIDMVRP 
 
   LONDON, Sept. 19, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces that it will present positive interim 
data from a Phase 2 trial with its dry powder inhaler formulation of 
ensifentrine in chronic obstructive pulmonary disease ("COPD") at the 
European Respiratory Society ("ERS") International Congress on Sunday, 
September 29, 2019 at 10:15 AM CEST. 
 
   These interim single dose data were first announced in March 2019 and 
followed by further positive results in August 2019 where all the 
primary and secondary lung function endpoints were met in the Phase 2 
trial. The magnitude of improvement in lung function and duration of 
action were highly statistically significant and support twice daily 
dosing of ensifentrine for the treatment of COPD. Results from the 7-day 
Phase 2 trial are available on Verona Pharma's website here 
https://www.globenewswire.com/Tracker?data=YvJU0I4lhs6iRBj4cIrQaDKEc_iVM6uOnleGRjCBo7iILMngNb1BK8nlPPKEEL2fsGYGg4qn5nftRsTj-K5VnR3f7Da1BM9DiZVbTJ_xe512qiKsje0woqPG_AZ4u073bToW3QP_QFHH4uVGGwynsA== 
. 
 
   Details of Verona Pharma's oral presentation are listed below and the 
abstract is available to the public online via the ERS website here 
https://www.globenewswire.com/Tracker?data=PT20hxXbfsX_eFKYlUx9WQG7YgsqLcFIuFLny-kTDvWvwq_2blNkbtohAggyvDcDE4shTy3Zp73KfkC79GIuCLf7ZCS69JeB82dDRUF9m_cXG9HO5PgZzrftQjRooWFZEKneULfLb-NjR3i26jutRw== 
. 
 
   Oral Presentation: Ensifentrine, a novel dual phosphodiesterase (PDE) 3 
and 4 inhibitor, provides effective bronchodilation when administered by 
dry powder inhaler in COPD 
 
   Presenter: Tara Rheault, Vice President, R&D and Global Project 
Management, Verona Pharma 
 
   Session 53: COPD clinical trials: new molecules and novel insights 
 
   Date / Time: Sunday September 29, 2019 at 10:15 AM CEST / 9:15 AM BST / 
4:15 AM ET 
 
   Location: IFEMA Exhibition Centre 
https://www.globenewswire.com/Tracker?data=ox4EiZSHcIANEOdTZfDDTv10AZ5rHj3P16xLInLXQCt_8LKLIvGQf_SZniu1wkSg28_eb3YT_UBiASM3H99Em5EaWpaI5i1TzRhc3-3ofVbhYfL5Dea4c1cUpoYKQMrI 
, Madrid; Room 6F 
 
   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 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 (LAMA/LABA +/- ICS) remain uncontrolled, experiencing 
symptoms that impair quality of life. These patients urgently need 
better treatments. 
 
   About Verona Pharma plc 
 
   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, ensifentrine (RPL554), is a first-in-class, 
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that 
has been shown to act as both a bronchodilator and an anti-inflammatory 
agent in a single compound. Three formulations of ensifentrine are under 
development for the treatment COPD: nebulized ensifentrine is currently 
in Phase 2b clinical development for the maintenance treatment of COPD 
and is planned to enter Phase 3 trials for this indication in 2020; a 
dry powder inhaler ("DPI") formulation reported positive Phase 2 data in 
August 2019; a pressurized metered-dose inhaler ("pMDI") formulation 
expects to report Phase 2 single dose data in the second half of 2019, 
with final data expected in the first quarter of 2020. Verona Pharma may 
also develop ensifentrine for the treatment of cystic fibrosis and 
asthma. 
 
   For more information, please visit veronapharma.com 
 
   About Ensifentrine 
 
   Nebulized ensifentrine 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 800 people to date 
 
   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 and data, estimates of medical 
costs for COPD, ensifentrine as a first-in-class phosphodiesterase 3 and 
4 inhibitor, and plans to develop ensifentrine for the treatment of 
cystic fibrosis and asthma. 
 
   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 Phase 2b trial; 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; 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 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 
Jan-Anders Karlsson, Chief Executive Officer       info@veronapharma.com 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                         Tel: +44 (0)20 3283 4200 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate 
 Finance) 
Mia Gardner (Corporate Broking) 
 
Optimum Strategic Communications                   Tel: +44 (0)20 950 9144 
 (European Media and Investor Enquiries)            verona@optimumcomms.com 
Mary Clark / Anne Marieke Ezendam / Hollie Vile 
 
Argot Partners                                     Tel: +1 212-600-1902 
 (US Investor enquiries)                            verona@argotpartners.com 
Stephanie Marks
(END) Dow Jones Newswires
September 19, 2019 02:00 ET (06:00 GMT)
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