VRP Verona Pharma Plc

 
TIDMVRP 
 
 
   New subgroup analysis supports ensifentrine's efficacy in symptomatic 
COPD patients 
 
   LONDON and RALEIGH, N.C., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Verona 
Pharma plc (AIM: VRP) (Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage 
biopharmaceutical company focused on respiratory diseases, announces 
that it will present new subgroup analysis from Phase 2b trials with 
nebulized ensifentrine in chronic obstructive pulmonary disease ("COPD") 
at the European Respiratory Society ("ERS") International Congress on 
Tuesday, September 8, 2020. The abstracts are available on the ERS 
website and will be published in a supplement of the September 2020 
edition of the peer reviewed journal, European Respiratory Journal. 
 
   Tara Rheault, Vice President, R&D and Global Project Management at 
Verona Pharma, will present subgroup analysis of Phase 2b data, first 
reported by Verona Pharma on 
https://www.globenewswire.com/Tracker?data=4DTXO6xUD4uES7LpPxGDvkQ7F-e6L0mZqXQ8Yz365iE-nn8r0WRi-aF3BJFb6BhzSmzBcBiDGdqknObKWwBA2pseBs0vWwH3fOFLaui8bFpuic1p0cnadMVpLcvnHH2qdJWYZWEHt2Qu__4QTSz_U3uolRM9_iljEm1QEmPwCb5YQ4i1_w6lh0HYdZlBJaK6 
January 13, 2020, and 
https://www.globenewswire.com/Tracker?data=x9VGkt8olkh0OC2Q9_8naTzHACTojc3NyhAmsRT5BukaxJYZoQQpVJgXH39F06ueCW2HmXcQTyjQZZwuxVLxpslk98ZxQtInd1oKZLmSJV6Oz1iGK1IMQ4wllaqDJl5KM5Z_3zQlY1MIPYgOBEgQsHfnUJl4i3Vuw8uuOMn1EcvtUrrR7nu5ZGLcUd1xh6Zw 
March 26, 2018, demonstrating that nebulized ensifentrine as monotherapy 
or added on to tiotropium (Spiriva(R) Respimat(R) ), a long acting 
anti-muscarinic ("LAMA") bronchodilator, improves lung function in 
moderate to severe COPD patients regardless of smoking status or history 
of chronic bronchitis over 4 weeks. 
 
   In addition to the oral presentation, Verona Pharma will highlight data 
demonstrating that nebulized ensifentrine added on to tiotropium over 4 
weeks improved lung function, symptoms and quality of life in moderate 
to severe COPD patients who were either reversible (>=12% and 200 mL) to 
albuterol and non-reversible (<12% or 200 mL) at screening compared to 
placebo added on to tiotropium. Importantly, in non-reversible patients, 
a large, clinically meaningful and statistically significant improvement 
in QoL as measured by SGRQ--C Total Score was observed. 
 
   Details of Verona Pharma's oral presentation and abstracts are listed 
below with links to the ERS website. 
 
   Oral Presentation OA4787: 
https://www.globenewswire.com/Tracker?data=FnsY4CFnGjA_0FS2Bhz-yPiIxTfPKd_lrWPDryDqncnLQJrg6kXyPPiEM_kge1MfIWLHu-WYoLP7276aKr2pr-5kelm5JusXKkra-AJ9CjfD72nd6ad4DC0mlmE4kufsA_0q6KS-pdtuRzYbMvMDBh35EU2pjPbdVSIUNL4tI5IBT_nBKSEg9Ut9bz5kvSFOMnGpRs6U-gLEEuPc6mSA8lFKQTIqnbEMUpHC12YfKIuvfjCVSsyveDI1swWUETKzGJQj4ojmS_53ggxcXzHJWqbuPTeMvNRkLZYyFivXl_U= 
Ensifentrine, a dual PDE3/PDE4 inhibitor, improves FEV(1) (1) regardless 
of smoking status or history of chronic bronchitis 
 
   Presenter: Tara Rheault, Vice President, R&D and Global Project 
Management, Verona Pharma 
 
   Channel 2: Cutting edge science: novel molecules and mechanisms of 
airway diseases 
 
   Session 415 
 
   Date / Time: Tuesday September 8, 2020 at 6:21 PM CEST / 5:21 PM BST / 
12:15 PM ET 
 
   Poster PA988: 
https://www.globenewswire.com/Tracker?data=FnsY4CFnGjA_0FS2Bhz-yKbyKaC5cTUvooTjtB7fvhFzN1oIDhfkPwi_OoouXbBw-oskiSOm1zKTgfeqKko4B8IEgnyyjWePYx0qJfJbltL7z5njWdHY5ZHRAQdriv7aP8PUBPh8KoDTN06dBzj6WfNOqYJhtAZkyqFHrLSZ11aWPtVg1Dh7vCuyGU5kZ7iselo-SKDY6tj6H96ZGCLmOpJWTTzCG5akW6lfJjcJqrRvnw8cUS935uSU0TaVWiNgTgwVBz1mPjTQW1dRr5Qz9CclbJrjKJ8PaqRJqXPoNG_tdwwNT7H4xuyJf_93-pqfD9YnZeGXIyWMO-3FGNGMSg== 
Ensifentrine added on to tiotropium significantly improves lung function, 
symptoms and QoL in symptomatic COPD patients regardless of baseline 
reversibility 
 
   Presenter: Kathleen Rickard, M.D., Chief Medical Officer, Verona Pharma 
 
   Pre-Congress Content: Clinical studies of COPD: combination inhalers and 
much more Session 84 
 
   (1) FEV(1) : Forced Expiratory Volume in one second, a standard measure 
of lung function 
 
   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 has demonstrated 
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 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. The Company plans to 
initiate its Phase 3 clinical program ENHANCE (Ensifentrine as a Novel 
inHAled Nebulized COPD thErapy) later in 2020 for nebulized ensifentrine 
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. Ensifentrine also has potential 
applications in COVID-19, 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, statements regarding the development and 
potential of ensifentrine, the initiation, progress and timing of 
clinical trials, ensifentrine as a first-in-class phosphodiesterase 3 
and 4 inhibitor, and plans to develop ensifentrine for the treatment of 
COVID-19, 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; 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; the loss of any key 
personnel and our ability to recruit replacement personnel, as well as 
the impact of our management team transition; 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; lawsuits related to patents covering 
ensifentrine and the potential for our patents to be found invalid or 
unenforceable; the impact of the COVID-19 pandemic on our operations, 
the continuity of our business and general economic conditions; and our 
vulnerability to natural disasters, global economic factors and other 
unexpected events, including health epidemics or pandemics like 
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, operational review, outlook and financial review. 
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 
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 
 
 
 
 
 
 

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August 24, 2020 02:00 ET (06:00 GMT)

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