Verona Pharma plc Verona Pharma Initiates Additional Phase 2b Clinical Trial With Nebulized Ensifentrine To Inform Dose Selec...

 
TIDMVRP 
 
   LONDON, May 07, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical 
company focused on respiratory diseases, announces the initiation of a 
Phase 2b dose-ranging study evaluating nebulized ensifentrine (RPL554) 
added on to a long acting bronchodilator in patients with 
moderate-to-severe chronic obstructive pulmonary disease ("COPD"). The 
Company anticipates reporting data around year end and commencing Phase 
3 clinical trials for this indication in 2020. 
 
   Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes 
phosphodiesterase 3 and 4 that has been shown to act both as a 
bronchodilator and anti-inflammatory agent in a single compound. 
 
   Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said: "In addition to 
further evaluating the potential of nebulized ensifentrine as a 
first-in-class therapy in symptomatic COPD patients already receiving a 
long-acting bronchodilator, this study is an important step towards 
optimizing the clinical profile of ensifentrine for the planned 
End-of-Phase 2 meeting with the FDA in the first half of 2020. The study 
is also expected to further inform the Phase 3 clinical development 
program for ensifentrine in terms of dose selection, patient population, 
background therapy and clinical endpoints." 
 
   The four-week, randomized, double-blind, dose-ranging Phase 2b trial 
plans to enroll about 400 patients with moderate-to-severe COPD to 
evaluate the safety and efficacy of nebulized ensifentrine when added on 
to inhaled tiotropium, a long-acting anti-muscarinic ("LAMA") commonly 
used to treat COPD. Patients will receive twice-a-day dosing for 28 days 
of nebulized ensifentrine at four dosage levels: 0.375 mg, 0.75 mg, 1.5 
mg and 3.0 mg. The trial is being performed at approximately 50 sites in 
the US. 
 
   The primary endpoint of the trial is improvement in lung function with 
ensifentrine after 4 weeks of treatment, as measured by peak forced 
expiratory volume in one second ("FEV(1) "), a standard measure of lung 
function. FEV(1) will be measured from 0 to 3 hours after dosing.  Key 
additional endpoints include measurements of respiratory symptoms and 
quality of life measures via different patient-reported outcome tools. 
 
   In prior 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. 
 
   In addition to advancing the nebulized formulation of ensifentrine 
through Phase 2b clinical development, Verona Pharma has also developed 
a dry powder inhaler ("DPI") and a pressurised metered dose inhaler 
("pMDI") formulation 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. 
 
   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 design of the 
Phase 2b clinical trial of ensifentrine, the timing of availability of 
data from the Phase 2b clinical trial, the importance of the Phase 2b 
clinical trial to our planned end-of-phase 2 meeting with the FDA and 
the  development plans for ensifentrine, the timing of the end-of-phase 
2 meeting with the FDA and the planned Phase 3 trials, the value of the 
data and insights that may be gathered from the Phase 2b clinical trial, 
including for the purpose of designing pivotal Phase 3 trials, and the 
potential of ensifentrine as a promising first-in-class treatment option 
for 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 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 Gardener (Corporate Broking) 
 
Optimum Strategic Communications                  Tel: +44 (0) 203 922 0891 
 (European Media and Investor enquiries)           verona@optimumcomms.com 
Mary Clark, Anne Marieke Ezendam, Hollie Vile 
 
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 07, 2019 02:01 ET (06:01 GMT)
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