Verona Pharma to Present Phase 2 Data with Ensifentrine Dry Powder Inhaler Formulation in COPD at European Respiratory Society International Congress 2019
LONDON, Sept. 19, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces that it will present positive interim data from a Phase 2 trial with its dry powder inhaler formulation of ensifentrine in chronic obstructive pulmonary disease (“COPD”) at the European Respiratory Society (“ERS”) International Congress on Sunday, September 29, 2019 at 10:15 AM CEST.
These interim single dose data were first announced in March 2019 and followed by further positive results in August 2019 where all the primary and secondary lung function endpoints were met in the Phase 2 trial. The magnitude of improvement in lung function and duration of action were highly statistically significant and support twice daily dosing of ensifentrine for the treatment of COPD. Results from the 7-day Phase 2 trial are available on Verona Pharma’s website here.
Details of Verona Pharma’s oral presentation are listed below and the abstract is available to the public online via the ERS website here.
Oral Presentation: Ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor, provides effective bronchodilation when administered by dry powder inhaler in COPD
Presenter: Tara Rheault, Vice President, R&D and Global Project Management, Verona Pharma
Session 53: COPD clinical trials: new molecules and novel insights
Date / Time: Sunday September 29, 2019 at 10:15 AM CEST / 9:15 AM BST / 4:15 AM ET
Location: IFEMA Exhibition Centre, Madrid; Room 6F
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 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 (LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.
About Verona Pharma plc
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. Verona Pharma’s product candidate, ensifentrine (RPL554), is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act as both a bronchodilator and an anti-inflammatory agent in a single compound. Three formulations of ensifentrine are under development for the treatment COPD: nebulized ensifentrine is currently in Phase 2b clinical development for the maintenance treatment of COPD and is planned to enter Phase 3 trials for this indication in 2020; a dry powder inhaler (“DPI”) formulation reported positive Phase 2 data in August 2019; a pressurized metered-dose inhaler (“pMDI”) formulation expects to report Phase 2 single dose data in the second half of 2019, with final data expected in the first quarter of 2020. Verona Pharma may also develop ensifentrine for the treatment of cystic fibrosis and asthma.
For more information, please visit veronapharma.com
Nebulized ensifentrine 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 800 people to date
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, estimates of medical costs for COPD, ensifentrine as a first-in-class phosphodiesterase 3 and 4 inhibitor, and plans to develop ensifentrine for the treatment of 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 and the completion of our Phase 2b trial; 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||[email protected]|
|Victoria Stewart, Director of Communications|
|N+1 Singer |
(Nominated Adviser and UK Broker)
|Tel: +44 (0)20 3283 4200|
|Aubrey Powell / Jen Boorer / Iqra Amin (Corporate Finance)|
|Mia Gardner (Corporate Broking)|
|Optimum Strategic Communications|
(European Media and Investor Enquiries)
|Tel: +44 (0)20 950 9144 |
|Mary Clark / Anne Marieke Ezendam / Hollie Vile|
(US Investor enquiries)
|Tel: +1 212-600-1902|
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