Verona Pharma plc Verona Pharma Initiates Phase 3 Clinical Trials With Nebulized Ensifentrine For The Maintenance Treatment O...

 
TIDMVRP 
 
   LONDON and RALEIGH, N.C., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Verona 
Pharma plc (AIM: VRP) (Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage 
biopharmaceutical company focused on respiratory diseases, announces the 
initiation of its ENHANCE ("Ensifentrine as a Novel inHAled Nebulized 
COPD thErapy") Phase 3 trials to evaluate the efficacy and safety of 
nebulized ensifentrine in patients with moderate to severe chronic 
obstructive pulmonary disease ("COPD"). 
 
   David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: 
"We are excited to start our pivotal ENHANCE Phase 3 studies. If 
successful, the data will support the submission of a New Drug 
Application in the U.S. for nebulized ensifentrine for the maintenance 
treatment of COPD. This is an important milestone for Verona Pharma and 
we look forward to addressing the urgent need for a novel therapy for 
the treatment of COPD." 
 
   Ensifentrine is a first-in-class product candidate that combines 
bronchodilator and anti-inflammatory activities in one compound. In 
prior clinical studies in COPD, ensifentrine has shown significant and 
clinically meaningful improvements in lung function, symptoms and 
quality of life as a monotherapy or added onto a maintenance 
bronchodilator. Ensifentrine has been well tolerated in clinical trials 
involving more than 1,300 subjects to date. 
 
   About the ENHANCE program 
 
   The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 
and ENHANCE-2) will evaluate the efficacy and safety of nebulized 
ensifentrine as monotherapy and added onto a single bronchodilator, 
either a LAMA ("long acting muscarinic antagonist") or a LABA ("long 
acting beta-agonist"), compared to placebo. The two study designs will 
replicate measurements of efficacy and safety data over 24 weeks and 
ENHANCE-1 will also evaluate longer-term safety over 48 weeks. 
 
 
   -- Patient Population: Each study will enroll approximately 800 moderate to 
      severe, symptomatic, COPD patients at sites primarily in the U.S. and 
      Europe. 
 
   -- Dose/Duration: Patients will be randomized to receive a 3 mg nebulized 
      dose of ensifentrine or nebulized placebo twice daily for 24 weeks in 
      ENHANCE-2 or 48 weeks in ENHANCE-1. 
 
   -- Primary Endpoint: Improvement in lung function as measured by forced 
      expiratory volume* in one second ("FEV1") over 12 hours with ensifentrine 
      after 12 weeks of treatment. 
 
   -- Key Secondary Endpoints: COPD symptoms and health-related quality of life 
      through 24 weeks via the validated patient reported outcome tools, SGRQ 
      and E-RS: COPD. Additional lung function endpoints including peak and 
      morning trough FEV1 will also be assessed. 
 
   -- Safety: Assessed over 24 weeks in both studies and over 48 weeks in 
      approximately 400 patients in ENHANCE-1. 
 
 
   Further information about this study can be found at 
www.clinicaltrials.gov, 
https://www.globenewswire.com/Tracker?data=SkGegTI8KbSxexWsSOWYMzlOA6kUea989nM5TOnf698wG1OGFlaizDXFgpmiToxcdzV1s7KtsY6x8G_0mCp4hiQjqVkF3kcZo97WfRbuLdAmt56jKdYhqglIWEAq1O7lOaDmcHqiCjIgqtjiKCf5jHTcl2MVPPoC1NJQ1fx_w1E= 
NCT04535986 (ENHANCE-1) and 
https://www.globenewswire.com/Tracker?data=SkGegTI8KbSxexWsSOWYMwf_NWYRgSfJls0f9xvr0Bl3AA8Oh9oyAtnEN0mPLixd-XCt1QAuiGcNm_r_MrGr7LjVh8Dx3KWyGvpW2AvZJvO2qgBTqJWjae5g0_wOfS1bksEQPy-hubzmU3BO9zNU5SKMSjpaUZBbR-0teKkabBk= 
NCT04542057 (ENHANCE-2). 
 
   (*) FEV(1) : Forced Expiratory Volume in one second, a standard measure 
of lung function 
 
   For further information, please contact: 
 
 
 
 
Verona Pharma plc                             Tel: +44 (0)20 3283 4200 
David Zaccardelli, Chief Executive Officer    info@veronapharma.com 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                    Tel: +44 (0)20 7496 3000 
(Nominated Adviser and UK Broker) 
Aubrey Powell / George Tzimas / Iqra Amin 
(Corporate Finance) 
Tom Salvesen (Corporate Broking) 
 
Optimum Strategic Communications              Tel: +44 (0)203 950 9144 
(European Media and Investor Enquiries)       verona@optimumcomms.com 
Mary Clark / Eva Haas / Shabnam Bashir 
 
Argot Partners                                Tel: +1 212-600-1902 
(US Investor Enquiries)                       verona@argotpartners.com 
Kimberly Minarovich / Michael Barron 
 
 
   About COPD 
 
   COPD is a progressive and life-threatening respiratory disease without a 
cure. It is the third leading cause of death globally, according to the 
World Health Organization. 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. U.S. sales of medicines used for chronic 
maintenance therapy of COPD were $9.6 billion in 2019. About 1.2 million 
U.S. 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 
 
   Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, 
dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and 
"PDE4"). This dual inhibition enables it to combine both bronchodilator 
and anti-inflammatory effects in one compound. Ensifentrine also 
activates the Cystic Fibrosis Transmembrane Conductance Regulator 
("CFTR"), which is beneficial in reducing mucous viscosity and improving 
mucociliary clearance. Ensifentrine's mechanism of action has the 
potential to alleviate respiratory symptoms such as breathlessness and 
cough and work against inflammation associated with COPD or inflammation 
triggered by viruses. 
 
   Ensifentrine has demonstrated significant and clinically meaningful 
improvements in both lung function and symptoms, including 
breathlessness, in Verona Pharma's Phase 2 clinical studies in patients 
with moderate to severe Chronic Obstructive Pulmonary Disease ("COPD"). 
In addition, nebulized ensifentrine showed further improved lung 
function and reduced lung volumes in COPD 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 1,300 subjects 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. The Company is evaluating 
nebulized ensifentrine in its Phase 3 clinical program ENHANCE 
("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD 
maintenance treatment. The Company raised gross proceeds of $200 million 
through a private placement in July 2020 and expects the funds to 
support its operations and Phase 3 clinical program into 2023. Two 
additional formulations of ensifentrine are currently in Phase 2 
development for the treatment of COPD: dry powder inhaler ("DPI") and 
pressurized metered-dose inhaler ("pMDI"). Ensifentrine is in a pilot 
clinical study in patients hospitalized with COVID-19 and has potential 
applications in cystic fibrosis, asthma and other respiratory diseases. 
For more information, please visit 
https://www.globenewswire.com/Tracker?data=vjECCSPndB1LMEwjAvclmo9PYI1UL3TpK-SIAG5tUYaKEH_KajPPDyH6hbKMvVroWwfdrGuOgFE74CmIR-Y7mPoDbDQDj_z8DAtHQPSTE3M= 
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 initiation of clinical trials, the goals and 
design of clinical trials, patient enrolment and study completion, 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 
effects in one compound, the potential of ensifentrine to alleviate 
respiratory symptoms such as breathlessness and cough and work against 
inflammation triggered by viruses, the Phase 3 clinical data supporting 
the submission of a New Drug Application in the U.S. for nebulized 
ensifentrine for the maintenance treatment of COPD, the sufficiency of 
funds to support its operations and Phase 3 clinical program into 2023, 
and the potential of ensifentrine in the treatment of COVID-19, COPD, 
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; and our vulnerability to natural disasters, global 
economic factors and other unexpected events, including health epidemics 
or pandemics like the novel coronavirus (COVID-19). 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 February 27, 2020, under the caption "Supplemental Risk Factor 
Disclosures" in our Report on Form 6-K filed with the SEC on April 30, 
2020, under the caption "Risk Factors" in our Registration Statement on 
Form F-1 filed with the SEC on August 17, 2020, 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.

(END) Dow Jones Newswires

September 23, 2020 04:06 ET (08:06 GMT)

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