VRP Verona Pharma Plc

 
TIDMVRP 
 
   Primary endpoint met at all doses: ensifentrine produced clinically and 
statistically significant dose-dependent improvements in lung function 
 
   Clinically relevant secondary endpoints met, including progressive and 
statistically significant improvements in quality of life 
 
   Conference call scheduled for 6.00 am PST / 9.00 am EST / 2.00 pm GMT on 
Monday, January 13, 2020 
 
   LONDON, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces positive top-line data from a 4 week, 
416 patient, Phase 2b dose-ranging study evaluating nebulized 
ensifentrine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or placebo as an 
add-on treatment to tiotropium (Spiriva(R) Respimat(R) ), a long acting 
anti-muscarinic ("LAMA") bronchodilator, in patients with moderate to 
severe chronic obstructive pulmonary disease ("COPD"). 
 
   The study met its primary endpoint of improved lung function, with 
ensifentrine added on to inhaled tiotropium, a LAMA commonly used to 
treat COPD. Ensifentrine produced a clinically and statistically 
significant, and dose-dependent improvement in peak forced expiratory 
volume in one second ("FEV(1) ")(1) at week 4 compared to placebo added 
on to tiotropium. 
 
   Highlights for ensifentrine as an add-on to tiotropium 
 
 
   -- Primary endpoint met at all doses: statistically significant and 
      clinically meaningful improvement in lung function at week 4. 
      Improvements ranged from 78 mL for the 0.375 mg dose (p=0.0368) to 124 mL 
      for the 3.0 mg dose (p=0.0008). Effects were maintained over 4 weeks. 
 
   -- Dose-dependent improvements in lung function were observed on both peak 
      FEV1 and FEV1 AUC 0-12 hours2. 
 
   -- Statistically significant improvement in average FEV1 AUC 0-12 hours of 
      87 mL for the 3.0 mg dose (p=0.0111) is supportive of twice daily dosing. 
 
   -- Clinically meaningful improvements in health-related quality of life 
      (mean SGRQ-C3) were observed on top of tiotropium, exceeding the minimal 
      clinically important difference ("MCID") of 4 units compared to placebo 
      at week 4, with the two highest doses also achieving statistical 
      significance. 
 
   -- Ensifentrine was well tolerated at all doses with an adverse event 
      profile similar to placebo. 
 
   -- These data support dose selection for Phase 3. 
 
 
   Gary Ferguson, MD, a pulmonary physician and Principle Investigator at 
the Pulmonary Research Institute of Southeast Michigan commented: "The 
strong effect on both bronchodilation and quality of life as an add-on 
to tiotropium is impressive and consistent with prior studies with 
ensifentrine. I am particularly interested to see the significant 
improvements in quality of life measurements over the 4 week treatment 
period. This is very important for patients that remain symptomatic 
despite using standard COPD medications." 
 
   Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said: "We are delighted 
with these results in symptomatic COPD patients already on steady-state 
maintenance treatment with a long-acting LAMA bronchodilator. These data 
bring clarity to planning the design, including dose selection, 
endpoints and background therapy, of our Phase 3 program. We look 
forward to discussing these new and compelling data, together with the 
positive results from our previous clinical studies, in an End-of-Phase 
2 meeting with the FDA planned for 2Q 2020. We are committed to 
demonstrating ensifentrine's potential to produce sustained 
bronchodilation and anti-inflammatory effects in symptomatic COPD 
patients in Phase 3 trials, which we expect to start in 3Q 2020." 
 
   Phase 2b Study Design 
 
   This 4 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 was 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 received nebulized ensifentrine at 4 dose levels: 0.375 mg, 
0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for 4 weeks. The 
trial's primary endpoint was improvement in lung function with 
ensifentrine after 4 weeks of treatment, as measured by peak FEV(1) , a 
standard measure of lung function. Key additional endpoints included 
other lung function measures, as well as measurements of symptoms 
associated with COPD and quality of life outcomes. 
 
   Full data from the Phase 2b study will be released at a subsequent 
scientific meeting, pending further data analysis. For further 
information on this clinical trial, please visit 
https://www.globenewswire.com/Tracker?data=KRq2rXgD9xFFeRfMY_OnbQzQ9HCWZz7UazKfZfZuUoz-IcagUGuh3azkYrgCx_e4ROwinPHabBeAuI0A3EdWgHFBxjgo9dld0UxSYbwCq3ZttqiUFhmvIYROsYXkbSkXpsqveFwba_zilqK-cEdsh8TrWy8L7JiiLk7CSbanPu8KnmQIo1sMn7OEs_olSQnF 
ClinicalTrials.gov, NCT03937479. 
 
   (1) FEV(1) : Forced Expiratory Volume in one second, a standard measure 
of lung function 
 
   (2) FEV(1) AUC(0-12hr) : Area Under the Curve over 0-12 hours post dose, 
calculated using the trapezoidal rule, divided by the observation time 
(12 hours) to report in mL, a measure of the aggregate effect over 12 
hours 
 
   (3) SGRQ-C: St. George's Respiratory Questionnaire is a validated 
instrument that measures impact on overall health, daily life, and 
perceived well-being in patients with COPD (i.e. change in frequency and 
severity of COPD symptoms, and impact on activities, social functioning 
and psychological disturbances related to airways disease) 
 
   Conference Call 
 
   Verona Pharma will host an investment community conference call today 
(Monday, January 13, 2020) at 6.00 am PST / 9.00 am EST / 2.00 pm GMT to 
discuss the Phase 2b study data. Analysts and investors may participate 
in the conference call using the conference ID: 2874368 and dialing the 
following numbers: 
 
 
   -- 866 940 4574 for callers in the United States 
 
   -- 0800 028 8438 for callers in the United Kingdom 
 
   -- 0800 181 5287 for callers in Germany 
 
 
   Those interested in listening to the conference call live via the 
internet may do so by visiting the "Events and Presentations" page on 
the "Investors" section of Verona Pharma's website at 
https://www.globenewswire.com/Tracker?data=80A_Zs63wMr4-jEBYUXCOLyhb7plc6aHEYHbqq68jNMLI8Yu_Xur1tLwdNN_5PG3jtDjWtzO6by3KCVjV87vKWj7zABsmJjS1yQ6vfwbGwOglNpM7o6lQAj_NkUkbTH74OpHYUE60Ix03clfgYzwSt85LzcYBeqNmN8eoTw7Ajo= 
www.veronapharma.com/investors/upcoming-events and clicking on the 
webcast link. Slides highlighting the data will also be posted to the 
"Events and Presentations" page. 
 
   THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF 
ARTICLE 7 OF REGULATION (EU) NO 596/2014. 
 
   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, 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 
 
   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 1250 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 
in Phase 2 development with three formulations of ensifentrine for the 
treatment of COPD: 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 
https://www.globenewswire.com/Tracker?data=80A_Zs63wMr4-jEBYUXCOKXWmYB5KRB3WoNZ8_lY0avW1m5ACba1xXT4QH_DdDWC9iQvr_hC_1zDyjakCoKwWFKwrVpYODkzIgOVun8LAwo= 
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 and data and meetings with the 
U.S. FDA, estimates of medical costs for COPD, 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 a single 

molecule, the distinct benefits of ensifentrine's novel mechanism of 
action in treating COPD, 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; 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 
David Moskowitz, VP Capital Markets Strategy & Investor 
 Relations (Investor enquiries) 
 Victoria Stewart, Director of Communications (Media 
 Enquiries) 
 
N+1 Singer                                               Tel: +44 (0)20 3283 4200 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / George Tzimas / Iqra Amin (Corporate 
 Finance) 
Mia Gardner (Corporate Broking) 
 
Optimum Strategic Communications                         Tel: +44 (0)20 950 9144 
 (European Media and Investor Enquiries)                  verona@optimumcomms.com 
Mary Clark / Eva Haas / Hollie Vile 
 
Argot Partners                                           Tel: +1 212-600-1902 
 (US Investor Enquiries)                                  verona@argotpartners.com 
Stephanie Marks / Kimberly Minarovich / Michael Barron 
 
 
 
 
 
 

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