Analysis confirms continued symptom benefits improving over time, supporting anti-inflammatory effects of ensifentrine in addition to bronchodilation
LONDON, May 20, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (VRP.L) (VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today presents clinically relevant findings from its chronic obstructive pulmonary disease (“COPD”) clinical trial program with lead product candidate, ensifentrine (RPL554), at the American Thoracic Society International Conference (“ATS”) in Dallas, TX. Positive results from the 4-week, 400-patient Phase 2b study were initially reported in March 2018.
The expanded analysis is supportive of the differentiated, dual mechanism of action of ensifentrine, as both a bronchodilator and an anti-inflammatory agent in a single compound. It provides further evidence of the potential for ensifentrine to provide significant symptom benefits to patients.
“These encouraging data suggest that ensifentrine’s dual mode of action combining anti-inflammatory and bronchodilator effects will lead to additional symptom benefits in COPD patients,” said Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit, University of Manchester, and presenter of the poster at ATS. “Importantly, ensifentrine was highly effective in improving symptoms independently of the magnitude of the bronchodilator response, suggesting that the activity of the PDE3/4 inhibitor is different to that of available bronchodilators when used alone or in combination. The anti-inflammatory activity may be responsible for this effect as it cannot be explained by bronchodilation alone.”
Details of the expanded analysis are available on Verona Pharma’s website here.
Details of the abstract were provided in the announcement dated May 2, 2019 and are available at the American Thoracic Society website at
Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown in several previous clinical studies to act both as a bronchodilator and an anti-inflammatory agent in a single compound. It is currently being evaluated in a further Phase 2b clinical trial as an add-on to standard therapy for the maintenance treatment of COPD, with data anticipated around year-end and expected to inform dose selection for Phase 3 trials. Verona Pharma expects to hold an end-of-Phase 2 meeting with the FDA in the first half of 2020 and plans to enter Phase 3 trials in 2020.
In addition to advancing the nebulized formulation, Verona Pharma has also developed dry powder inhaler (“DPI”) and pressurized metered dose inhaler (“pMDI”) formulations of ensifentrine. In an ongoing Phase 2 clinical trial, the DPI formulation demonstrated dose-dependent, significant bronchodilation following a single dose, and is currently being evaluated over one week of twice-daily treatment, with top-line data expected in the third quarter this year. The pMDI formulation is planned to enter clinical evaluation in a Phase 2 study in COPD patients later this quarter.
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 2010 total annual medical costs related to COPD were estimated to be $32 billion and are projected to rise to $49 billion in 2020. About 800,000 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. 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. Verona Pharma may also develop ensifentrine for the treatment of cystic fibrosis and asthma.
In Phase 2 clinical studies in patients with moderate to severe COPD, ensifentrine has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness. In addition, ensifentrine has 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, statements regarding the value of trial results presented at ATS, ensifentrine as a new complementary treatment for patients with COPD, statements that there is an opportunity for additional symptom improvement via ensifentrine’s novel mechanism of action, the expectation that our Phase 2b study will inform the dose selection for Phase 3, the expected timelines for trial data, the end-of-Phase 2 FDA meeting and initiation of Phase 3, the future clinical development and positioning of ensifentrine, and the projected annual medical costs related to COPD.
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; 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 Officerfirstname.lastname@example.org|
|Victoria Stewart, Director of Communications|
|N+1 Singer||Tel: +44 (0)20 3283 4200|
|(Nominated Adviser and UK Broker) |
Aubrey Powell /Jen Boorer /Iqra Amin (Corporate Finance)
Mia Gardener (Corporate Broking)
|Optimum Strategic Communications |
(European Media and Investor enquiries)
|Mary Clark, Anne Marieke Ezendam, Hollie Vile||Tel: +44 (0) 203 922 0891 |
|Westwicke, an ICR Company |
(US Media and Investor enquiries)
|Darcie Robinson||Tel: +1 203-919-7905 |
|Stephanie Carrington||Tel. +1 646-277-1282 |