Verona Pharma plc Verona Pharma Completes Enrollment In Phase 2b Clinical Trial With Nebulized Ensifentrine In Moderate-to-se...

 
TIDMVRP 
 
 
   Results to Inform Development Plan and Dose Selection for Phase 3 
 
   LONDON, Oct. 17, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces that it has randomized the last patient 
in its Phase 2b dose-ranging study evaluating the effect of nebulized 
ensifentrine as an add-on to treatment with a long acting bronchodilator 
in patients with moderate-to-severe chronic obstructive pulmonary 
disease ("COPD"). 
 
   Ensifentrine has the potential to be the first novel class of 
bronchodilator in over 40 years, and the first therapy for the treatment 
of respiratory diseases that combines bronchodilator and 
anti-inflammatory activities in one compound. The addition of nebulized 
ensifentrine to symptomatic COPD patients already treated with 
standard-of-care medicines represents a significant market opportunity. 
 
   Highlights: 
 
 
   -- Enrollment completed on schedule with data expected around year end 2019 
 
 
   -- Preparations underway for End-of-Phase 2 meeting with the U.S. FDA 
      expected in the first half of 2020 
 
 
   -- Commencement of Phase 3 trials expected in 2020 
 
 
   "We remain on track to deliver data from this important Phase 2b 
clinical trial in patients with moderate-to-severe COPD around year end 
2019," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We expect 
this second Phase 2 study with nebulized ensifentrine in COPD to help 
inform our planned Phase 3 clinical development program, which we expect 
to start in 2020. Millions of COPD patients urgently need better 
treatments as they remain symptomatic despite maximum treatment with 
currently available therapies. We believe ensifentrine, with its unique 
mode of action and clinical profile, will have an important role in 
treating these patients." 
 
   This four-week randomized, double-blind, placebo-controlled dose-ranging 
Phase 2b trial enrolled a total of 416 patients with moderate-to-severe 
symptomatic COPD at 46 sites in the U.S. The trial is designed to 
evaluate the safety and efficacy of nebulized ensifentrine as an add-on 
to inhaled tiotropium, a long acting anti-muscarinic ("LAMA") commonly 
used to treat patients with COPD. 
 
   Patients will receive nebulized ensifentrine at four dose levels: 0.375 
mg, 0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for four weeks. 
The trial's primary endpoint is improvement in lung function with 
ensifentrine after four weeks of treatment, as measured by peak forced 
expiratory volume in one second ("FEV(1) "), a standard measure of lung 
function. Key additional endpoints include other lung function measures, 
as well as measurements of symptoms associated with COPD and quality of 
life outcomes. For further information on this clinical trial, please 
visit 
https://www.globenewswire.com/Tracker?data=ctF4xP9ZDsOu5M7etUH5FXGnUM6vQO0N1uhz0ISzqP5wA60S19oXTEfw_fa0eKuDaymIilXyFz3YBgbUl4kwpK2AqDxCVmqmSHBiA1VgcToFwBT4KG3KRoMKZlNhxmMpp-URgB2LbvcVPgRNP489SHkmqijbVMBpW7kphwDyzra90jXm91ulr_2w11RP8J6N 
ClinicalTrials.gov, NCT03937479. 
 
   Verona Pharma is also developing two additional formulations of 
ensifentrine, a dry powder inhaler ("DPI") and a pressurized 
metered-dose inhaler ("pMDI"). In July 2019, the company reported 
positive data from its Phase 2 trial with the DPI formulation, which 
demonstrated statistically significant and clinically meaningful 
dose-dependent improvements in lung function in moderate-to-severe COPD. 
Verona Pharma is conducting a Phase 2 trial with the pMDI formulation 
and expects to report data from the first part of the trial in the 
fourth quarter of 2019, with final data expected in the first half of 
2020. 
 
   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 (LAMA/LABA +/- 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 800 people to date. 
 
   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, 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 fourth quarter of 
2019, with final data expected in the first half of 2020. Verona Pharma 
may also develop ensifentrine for the treatment of cystic fibrosis and 
asthma. 
 
   For more information, please visit 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, 
including the design of clinical trials, the progress and timing of 
clinical trials and data and meetings with the U.S. FDA, estimates of 
medical costs for COPD and its status as a leading cause of death 
worldwide, ensifentrine as the first novel class of bronchodilator in 
over 40 years and the first to combine bronchodilator and 
anti-inflammatory activities and a first-in-class phosphodiesterase 3 
and 4 inhibitor, the market opportunity for ensifentrine, the Phase 2b 
clinical trial with nebulized ensifentrine informing the Phase 3 
clinical development program, the impact of ensifentrine in treating 
COPD patients, 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: [phone] 
Jan-Anders Karlsson, Chief Executive Officer       [e-mail] 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                         Tel: [phone] 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate 
 Finance) 
Mia Gardner (Corporate Broking) 
 
Optimum Strategic Communications                   Tel: [phone] 
 (European Media and Investor Enquiries)            [e-mail] 
Mary Clark / Eva Haas / Hollie Vile 
 
Argot Partners                                     Tel: [phone] 
 (US Investor enquiries)                            [e-mail] 
Stephanie Marks 
 
 
 
 
 
 

(END) Dow Jones Newswires

October 17, 2019 02:00 ET (06:00 GMT)

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