Verona Pharma plc Verona Pharma Announces Fda Response Toend-of-Phase 2 Briefing Package For Ensifentrine In Copd And Outline...

 
TIDMVRP 
 
   LONDON, May 14, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical 
company focused on respiratory diseases, announces that it has received 
written comments from the U.S. Food and Drug Administration (FDA) in 
response to its End-of-Phase 2 briefing package for nebulized 
ensifentrine as a maintenance treatment for chronic obstructive 
pulmonary disease ("COPD"). The response supports Verona Pharma 
progressing with its planned Phase 3 clinical program, which is expected 
to start later in 2020. It is planned to be called the ENHANCE 
(Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program. 
 
   The FDA's comments follow its review of the End-of-Phase 2 briefing 
package that included data from 16 clinical trials involving over 1,300 
subjects as well as supportive nonclinical and product development data. 
Verona Pharma has obtained clarity from the FDA on important features of 
the pivotal Phase 3 clinical program to support a New Drug Application 
(NDA) including: dose, primary and secondary endpoints, patient 
population and program design. Based on the FDA response, Verona Pharma 
is accelerating preparations for the Phase 3 clinical program to start 
later in 2020. 
 
   The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 
and ENHANCE-2) will evaluate the efficacy and safety of twice daily 
nebulized ensifentrine as monotherapy and as an add-on to standard of 
care treatment with a single bronchodilator, either a LAMA, long acting 
muscarinic antagonist, or a LABA, long acting beta-agonist. The two 
study designs are essentially identical over 24 weeks but ENHANCE-1 will 
also evaluate longer-term safety. 
 
 
   -- Patient Population: Each of the studies will be expected to enroll 
      approximately 800 moderate to severe, symptomatic COPD patients at sites 
      primarily in the US and Europe. 
 
   -- Dose/Duration: Patients will receive 3 mg nebulized ensifentrine or 
      nebulized placebo twice daily. 
 
   -- 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: Peak and trough FEV1 as well as COPD symptoms 
      and health-related quality of life will be assessed through 24 weeks via 
      the validated patient reported outcome tools, SGRQ and E-RS: COPD. 
 
   -- Safety: Assessed over 24 weeks in both studies and over 48 weeks in 
      approximately 400 patients in ENHANCE-1. 
 
 
   "We are very pleased with the FDA's response to our End-of-Phase 2 
briefing package. Subject to securing additional funding, we look 
forward to starting our pivotal ENHANCE program later in 2020," said 
David Zaccardelli, Pharm. D., President and Chief Executive Officer. "We 
continue to be very encouraged by the Phase 2 results that have 
demonstrated ensifentrine's effects on lung function, COPD symptoms and 
quality of life as well as its favorable safety profile. We look forward 
to building on this positive data to support the potential submission of 
a NDA for ensifentrine for the maintenance treatment of COPD." 
 
   Conference Call on June 1 at 7:30 a.m. EDT / 12:30 pm BST 
 
   Verona Pharma plans to present an overview of its ENHANCE program on an 
investor and analyst R&D webcast at 7:30 a.m. EDT / 12:30 p.m. BST on 
Monday June 1, 2020. The event will provide insight into the significant 
unmet need and challenges of treating COPD as well as further details of 
the ENHANCE program. In additional to members of Verona Pharma's 
management team, the webcast will feature a panel of Key Opinion Leaders 
in the field of COPD to provide a clinician's perspective. Analysts and 
investors will be invited to participate in a live webcast available on 
the Investors page of the Company's website, www.veronapharma.com, where 
an audio replay will also be available for 30 days. 
 
   Verona Pharma continues to monitor the situation caused by the COVID-19 
pandemic and its potential impact on its operational, planned clinical 
trials and the potential disruption to financial markets. 
 
   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. US sales of medicines 
used for chronic maintenance therapy of COPD were $9.6 billion in 2019. 
About 1.2 million US 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) 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, 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 1,300 
people 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. Verona Pharma is currently 
evaluating three formulations of ensifentrine for the treatment of COPD 
in Phase 2 clinical trials: nebulized, dry powder inhaler, and 
pressurized metered-dose inhaler. Ensifentrine also has potential 
applications in cystic fibrosis, asthma and other respiratory diseases. 
For more information, please visit 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 clinical trials, data and meetings with and 
written feedback from the FDA, 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 activities in one compound, the 
potential for ensifentrine to have a significant impact on the treatment 
of COPD, estimates of medical costs for COPD and the number of 
symptomatic COPD patients, and the potential application of ensifentrine 
for the treatment of 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, 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. 
 
   THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF 
ARTICLE 7 OF REGULATION (EU) NO 596/2014 
 
   For further information, please contact: 
 
 
 
 
Verona Pharma plc                                     Tel: [phone] 
David Zaccardelli, Chief Executive Officer            [e-mail] 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                            Tel: [phone] 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / George Tzimas / Iqra Amin (Corporate 
 Finance) 
Tom Salvesen (Corporate Broking) 
 
Optimum Strategic Communications                      Tel: [phone] 
 (European Media and Investor Enquiries)               [e-mail] 
Mary Clark / Eva Haas / Shabnam Bashir 
 
Argot Partners                                        Tel: [phone] 
 (US Investor Enquiries)                               [e-mail] 
Stephanie Marks / Kimberly Minarovich / Michael 
Barron 
 
 
 
 
 
 

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May 14, 2020 02:00 ET (06:00 GMT)

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