Verona Pharma plc Verona Pharma Presents Expanded Analysis Of Ensifentrine Clinical Data In Copd Maintenance Treatment At The...
May 01 2020 - 12:12PM
UK Regulatory
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: +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 3283 4200
(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
Stephanie Marks / Kimberly Minarovich / Michael
Barron
(END) Dow Jones Newswires
May 01, 2020 12:12 ET (16:12 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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