Verona Pharma plc Verona Pharma Presents Expanded Analysis Of Ensifentrine Clinical Data In Copd Maintenance Treatment At The...

 
TIDMVRP 
 
   Analysis supports ensifentrine's efficacy in COPD as monotherapy and on 
top of standard of care treatment in patients who remain symptomatic 
 
   Six abstracts accepted demonstrating ensifentrine's potential across 
treatment settings and formulations 
 
   LONDON, May 01, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical 
company focused on respiratory diseases, announces that six abstracts 
presenting clinically relevant findings from its clinical trials with 
first-in-class development candidate, ensifentrine, for the treatment of 
chronic obstructive pulmonary disease ("COPD") have been accepted by the 
American Thoracic Society International Conference ("ATS") 2020. The 
abstracts are published on the ATS website and today in the peer 
reviewed publication, American Journal of Respiratory and Critical Care 
Medicine. 
 
   The presentations include a late-breaking abstract that expands on Phase 
2b efficacy and symptom data first announced by the Company on 
https://www.globenewswire.com/Tracker?data=pyuH3ffWv5JEnNaQ2vkwvnoX5Lhg7tEKemnr0VL5IR9LpEG5Q2aScXs-dibdRLyFylWaAa1IK8kgD6hOZJBHEFdKUsQTwIwHCZcDGNpGyg-aeqp9Le5IkhzmOo12GlIru0qBHxWpEmxVHe_JNR02PNHU3A6JtBjJ_BHIfAH5cC3JkUYyJJUMGK0dUbfCw9VS 
January 13, 2020 where nebulized ensifentrine added on to tiotropium 
demonstrated clinically and statistically significant dose-dependent 
improvements in lung function as well as COPD symptoms. Other abstracts 
include clinical data from three previous studies that demonstrate 
ensifentrine's potential in additional treatment settings and with the 
dry powder formulation. These include further analyses of positive Phase 
2b efficacy (subgroup analysis), symptom (responder analysis) and safety 
data with nebulized ensifentrine as a monotherapy in patients with COPD 
as well as an analysis of additional lung function improvement when 
nebulized ensifentrine was added to dual COPD therapy. In addition, one 
abstract analyses positive Phase 2 data with ensifentrine in a dry 
powder inhaler formulation dosed over 7 days in patients with COPD. 
 
   Gary T. Ferguson, MD, Director of the Pulmonary Research Institute of 
Southeast Michigan and Principal Investigator in the Phase 2b study that 
evaluated ensifentrine added on to tiotropium commented: "Ensifentrine 
has demonstrated significant additional benefits to bronchodilation, 
symptoms and quality of life when used as an add-on therapy to 
tiotropium. I am especially encouraged by the significant improvements 
in quality of life measurements over the 4 week treatment period. This 
is very important for patients who remain symptomatic despite using 
standard COPD medications and supports the potential for ensifentrine to 
provide a meaningful difference in the treatment of COPD patients." 
 
   Details of Verona Pharma's six abstracts are listed below with links to 
the ATS website. 
 
   Late-breaking Abstract: A4213 -- Ensifentrine Provides Significant and 
Clinically Meaningful Bronchodilation and Quality of Life Improvement on 
Top of Tiotropium in Symptomatic COPD Patients in a 4-Week Dose-Ranging 
Study 
https://www.globenewswire.com/Tracker?data=etJe98q91_04G2T_jiduNzbXV2W_IqTiZlp72AGNHnHHurlsaaVm2WsJ8wTllonesaQCDJFcm_8ytEKbdiLoAQEX5FBxR15kQ8BQh-M9AgR-ccKPyAag1PC6dKlg_u_oTlXW5n7_zGdcWIUGMqlaq-zC786pTn-LPJucl7P7oDB7YIms2pBkroDnRXF7MAEb4dKxApqXUs5_Bql-o8DKNF6Ga4Q3qs94XSYtD41h4_b4o3x6lVuIFI5GCgsDXmQCWaJzGx1d2fuxUcJBwc2nvCHjOE2IEsJTVO8UcMh5FB82S-RkBJH8YeJHtAoQT-MhjXfIU0YiZzZzUhGqopkYe_da-fcYf9nZDlCXws_XEE10A2FQLbErW1lw9BeZZRzS 
 
 
   Participant: Gary Ferguson, Principal Investigator, Pulmonary Research 
Institute of Southeast Michigan, Farmington Hills, MI, US 
 
   Session: B93 -- Late Breaking Clinical Trials in Airway Diseases 
 
   Abstract: 
https://www.globenewswire.com/Tracker?data=XNMqFp9EdfMiTsJwss9sX5uID4u7Cib5T_CBb1bu0Q6eYUSgCPHTMZSFzK3Pk2L0f4gwl3qr0FU3u9zaWzCB0X-Fk4UjbIMUdSquIW41rNEjPnl49-BNTUUh37NqTGoeDd0FdHbCkoAinEgjZV8A4XyKYiHt13ldiVjWFT--PKrG5VuBuSGe7ruKzLWUdD2fnXnkyw1c-VeoFkdBOinCywb3Z_qZhhjVK_G4EYHinaOtSOhizecYaVFl-BBQShb_XX80b7fnD91TLRPVmtX78Fwif9jGNrxx-6q45JE4jKdzG-JftuDe8k2VNkXKBdfh 
A4578 -- Responder Analyses For Symptom And QoL (E-RS, TDI And SGRQ-C) 
Improvement With Nebulized Ensifentrine Dosed Twice Daily Over 4 Weeks 
 
   Participant: Tara Rheault, Vice President, R&D and Global Project 
Management, Verona Pharma 
 
   Session: C23. Assessment of Outcome Risk in Obstructive Lung Disease 
 
   Abstract: 
https://www.globenewswire.com/Tracker?data=ABCaDuk-ztzGdzfHtoIpV1iXonFOD-lPCuGyC7ATP-jiEItJpr5smIr6t_wMpV76fM1CYOnp7Wafl_YZxZakszVrnxcXuohxoz1hdepR9GC9ulEZVSX3hA9oHWaAYsGfXPuG0F5yH0Ij1UnzTTIBTKcOLax9_8-jKWfSpI-MwBC0kI5OTkttYLtmCgJP1zQWO2i_GHQy_UHFCfSsSA5KuThvgzKyaezgaTDZJMP8lepBvfh8S20hTnNfom9tIruO9PlRq6UMsZtVN4N67xMQqHPQvw8rx1Y3sJBJPthrAxxqaaTCe3pCUHBqE5KFI-Pk 
A3323 -- Safety of Ensifentrine, a Dual PDE3/4 Inhibitor: Results of 
Reported GI and CV Events from a Four Week Randomized, Controlled Trial 
 
   Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma 
 
   Session: B41. Therapeutic Intervention, Quality Improvement and 
Treatment Adherence in Obstructive Lung Disease 
 
   Abstract: 
https://www.globenewswire.com/Tracker?data=Sq0HMpbdZ75FzcF5PiwZZY5oEDk2wMEjC2mz6gzjOsVrxQsLtAEqWj9Z15jNF1qvf22PAsnw97naJUkEmzjuj5X8u7QGYIvuHJqoiFAJlY1J57JmGKZEwtA-6HC3sGQzfphy5yB26AOecXq9qOHOjscGCpQz35mWqFcDRu3AIR_lRESXPqNk9ZmZQMA8PEmOzwlZFNjJsRvPjSXm3KHWmYYV0wXbfTKIoXERd80jb4i0pIP3Bi4YjNrBI-MHKjYvEPWgKB-hI19h7B__IEENVnVRaYLG8890_fc1THPZEx8ebVPuuPSx39U3hxEYuQR5lqLtCEDIkv7YA2GfdloABkoWNpxQgOmHVCmA9BFKxOY= 
A4297 -- Bronchodilation and Symptom Improvement with Ensifentrine, A 
Dual PDE3/4 Inhibitor: Sub-Group Analyses of a Four Week Randomized, 
Controlled Trial in Patients with COPD 
 
   Participant: Tara Rheault, Vice President, R&D and Global Project 
Management, Verona Pharma 
 
   Session: B103. Treatment of Obstructive Lung Disease 
 
   Abstract: 
https://www.globenewswire.com/Tracker?data=FHLoVSFlPz4DNIXyVI2SDaY_D9uiXCkhTPuHrTCIZAgJUQ0Vk9k9RzPsl6iyodwmB5lWmuDygVJzCmlJoDz4Q8_01jyphCtmrVed29OAZs6IbLgpOYEGHhP2e9IRT3qvUdQKSTx-hQy1-GC3gmimfWEllJs1eJdWpBlJtZ-n79RqtdGBARyCHVkY97LUjKemBhvRiT9OjwDceznbQXP3NhnZ_oWim2XC5-Z7ti3o2eVUqUzWFJONcCA4EHf_Ug8SqiRyMPzh5sVMW-t-jBrms271X08Es6r1riiHfMjPDzTpfqYGfimGugfBfS6iCENM 
A4298 -- Additional Bronchodilation by Ensifentrine, A Dual PDE3/4 
Inhibitor, When Combined with a LAMA/LABA in Patients with Moderate to 
Severe COPD 
 
   Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma 
 
   Session: B103. Treatment of Obstructive Lung Disease 
 
   Abstract: 
https://www.globenewswire.com/Tracker?data=xJZKlRrkGB-lsi8kuADDLhN0c5GdN-YDbg18-hadc0QRQLPfi5jDFXUkkuAj7thmuhOlnSTkfRJnlRnrd1HUym74O90AiJdBPewM-0Yuw2Gtwmv977J27UxgcKyyIQyXmBIkt6Njjm0bvsF5RI9JlaBla-aL9DvbbIJMiHdKerzZSt1eRTsi3SnME41fqVnEPuKRg3ntkGND3YABqOe0MisW4xvD7CxgrmVGuPJR35abV1CiD_v99z-v-yIw26jppvOmF1BFlqt9xLMBMU_i-ydlmcslM9_-WSj-gFBYvt0jdaCYkHFtk8zADX7_pHB5d_e6HE09eqZbDmhAmChaDCwztfQjVV18XYoDnmUJf-M= 
A4296 -- Ensifentrine, A Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, 
Provides Effective Bronchodilation in COPD When Administered Twice Daily 
Over 7 Days Via a Dry Powder Inhaler 
 
   Participant: Tara Rheault, Vice President, R&D and Global Project 
Management, Verona Pharma 
 
   Session: B103. Treatment of Obstructive Lung Disease 
 
   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 1300 
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 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. 
 
   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 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

May 01, 2020 12:12 ET (16:12 GMT)

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