VRP Verona Pharma Plc

 
TIDMVRP 
 
 
   Analysis confirms continued symptom benefits improving over time, 
supporting anti-inflammatory effects of ensifentrine in addition to 
bronchodilation 
 
   LONDON, May 20, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical 
company focused on respiratory diseases, today presents clinically 
relevant findings from its chronic obstructive pulmonary disease 
("COPD") clinical trial program with lead product candidate, 
ensifentrine (RPL554), at the American Thoracic Society International 
Conference ("ATS") in Dallas, TX. Positive results from the 4-week, 
400-patient Phase 2b study were initially reported in March 2018. 
 
   The expanded analysis is supportive of the differentiated, dual 
mechanism of action of ensifentrine, as both a bronchodilator and an 
anti-inflammatory agent in a single compound. It provides further 
evidence of the potential for ensifentrine to provide significant 
symptom benefits to patients. 
 
   "These encouraging data suggest that ensifentrine's dual mode of action 
combining anti-inflammatory and bronchodilator effects will lead to 
additional symptom benefits in COPD patients," said Dave Singh, M.D., 
Professor of Clinical Pharmacology and Respiratory Medicine, Medicines 
Evaluation Unit, University of Manchester, and presenter of the poster 
at ATS. "Importantly, ensifentrine was highly effective in improving 
symptoms independently of the magnitude of the bronchodilator response, 
suggesting that the activity of the PDE3/4 inhibitor is different to 
that of available bronchodilators when used alone or in combination. The 
anti-inflammatory activity may be responsible for this effect as it 
cannot be explained by bronchodilation alone." 
 
   Details of the expanded analysis are available on Verona Pharma's 
website 
https://www.globenewswire.com/Tracker?data=LHkRU74j7IhGgyNbYXORnbZpoird6r6nzak1NmQWynuLGWVEkPWY3DtwY17AGVzkmoCrhy_tikPXcUxtL5V28NjlfDQLJUz9BZwuEcRbYQZTq4LF52foAmN1qxg4jbnP 
here. 
 
   Details of the abstract were provided in the 
https://www.globenewswire.com/Tracker?data=mLKh4_KDPCsfL2i7UFnZGVJYs4hkAtME8vwC_YenMeFI84n-fw35XtIHHPAN1qs2o-_noy0jqcNCLpaikel4bk5zESnfMQQQZveWL8xEPg1t5PdoaUC6SPLLfelZtlPj4cYgr5So-5sVHhMikNsDJxOquthsHZpGTuYAAKhZp2hCLPBRZ5uSoMNZHAIwnTnBZxx3wfyFanWhDocpqzsAQrwAheLm_tibkmwE6NI_yuCdrATC2nCrbdMAZqmkHQE-BeiKaGGVTefPz-H9Yh1yuw== 
announcement dated May 2, 2019 and are available at the American 
Thoracic Society website at 
 
   https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A3846 
 
 
   Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes 
phosphodiesterase 3 and 4 that has been shown in several previous 
clinical studies to act both as a bronchodilator and an 
anti-inflammatory agent in a single compound. It is currently being 
evaluated in a further Phase 2b clinical trial as an add-on to standard 
therapy for the maintenance treatment of COPD, with data anticipated 
around year-end and expected to inform dose selection for Phase 3 
trials. Verona Pharma expects to hold an end-of-Phase 2 meeting with the 
FDA in the first half of 2020 and plans to enter Phase 3 trials in 2020. 
 
   In addition to advancing the nebulized formulation, Verona Pharma has 
also developed dry powder inhaler ("DPI") and pressurized metered dose 
inhaler ("pMDI") formulations of ensifentrine. In an ongoing Phase 2 
clinical trial, the DPI formulation demonstrated dose-dependent, 
significant bronchodilation following a single dose, and is currently 
being evaluated over one week of twice-daily treatment, with top-line 
data expected in the third quarter this year. The pMDI formulation is 
planned to enter clinical evaluation in a Phase 2 study in COPD patients 
later this quarter. 
 
   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 2010 total annual medical costs related to COPD were 
estimated to be $32 billion and are projected to rise to $49 billion in 
2020. About 800,000 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. 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. Verona 
Pharma may also develop ensifentrine for the treatment of cystic 
fibrosis and asthma. 
 
   In Phase 2 clinical studies in patients with moderate to severe COPD, 
ensifentrine has shown significant and clinically meaningful 
improvements in both lung function and COPD symptoms, including 
breathlessness. In addition, ensifentrine has 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, statements regarding the value of trial 
results presented at ATS, ensifentrine as a new complementary treatment 
for patients with COPD, statements that there is an opportunity for 
additional symptom improvement via ensifentrine's novel mechanism of 
action, the expectation that our Phase 2b study will inform the dose 
selection for Phase 3, the expected timelines for trial data, the 
end-of-Phase 2 FDA meeting and initiation of Phase 3, the future 
clinical development and positioning of ensifentrine, and the projected 
annual medical costs related to COPD. 
 
   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; 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 Gardener (Corporate Broking) 
Optimum Strategic Communications 
 (European Media and Investor enquiries) 

Mary Clark, Anne Marieke Ezendam, Hollie Vile              Tel: +44 (0) 203 922 0891 
                                                            verona@optimumcomms.com 
Westwicke, an ICR Company 
 (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 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

May 20, 2019 10:16 ET (14:16 GMT)

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