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 January 13, 2020, and March 26, 2018, demonstrating that nebulized ensifentrine as monotherapy or added on to tiotropium (Spiriva® Respimat®), 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: Ensifentrine, a dual PDE3/PDE4 inhibitor, improves FEV11 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
Date / Time: Tuesday September 8, 2020 at 6:21 PM CEST / 5:21 PM BST / 12:15 PM ET
Poster PA988: 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 FEV1: Forced Expiratory Volume in one second, a standard measure of lung function
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.
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