Verona Pharma Presents Pharmacokinetic Data with Ensifentrine at the European Respiratory Society International Congress 2021
Verona Pharma (Nasdaq: VRNA) announced the publication of an abstract regarding a study on the drug-drug interaction between fluconazole and ensifentrine, presented at the European Respiratory Society International Congress 2021. The Phase 1 study indicated that co-administration of fluconazole with nebulized ensifentrine showed minimal, clinically irrelevant effects on ensifentrine pharmacokinetics. The company continues its Phase 3 program for ensifentrine to treat COPD, with top-line results expected in 2022.
- Fluconazole co-administration showed minimal effect on ensifentrine pharmacokinetics, indicating good compatibility.
- Ensifentrine has demonstrated significant improvements in lung function and symptoms in prior studies.
- Ongoing Phase 3 clinical trials suggest potential for successful FDA approval.
- Dependence on successful development of ensifentrine as the only product candidate raises execution risks.
- Potential delays in clinical trials could affect overall development timelines.
Results demonstrate co-administration of fluconazole has minimal effect on ensifentrine pharmacokinetics
LONDON and RALEIGH, N.C., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces an abstract describing a drug-drug interaction study assessing the effect of CYP2C9 inhibitor, fluconazole, on the pharmacokinetics of nebulized ensifentrine in healthy individuals has been published by the European Respiratory Society (“ERS”) International Congress 2021. The abstract is available on the ERS website and will appear in a supplement of the peer reviewed journal, European Respiratory Journal.
Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) and is primarily metabolized via the hepatic route by the cytochrome P450 enzyme, CYP2C9. Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) with top-line results expected in 2022.
The Phase 1, open label, 29-patient study demonstrated co-administration of oral, steady-state fluconazole with inhaled ensifentrine was well tolerated and had a minimal, not clinically relevant, effect on the pharmacokinetic profile of ensifentrine.
Details of Verona Pharma’s abstract are listed below and linked to the ERS website.
E-poster 2137: The effect of fluconazole on the pharmacokinetics of ensifentrine in healthy individuals
Participant: Tara Rheault, Vice President of Research and Development, Verona Pharma
Pre-Congress Content: Pharmacology of airway diseases: clinical and laboratory studies
For further information please contact:
| Verona Pharma plc | US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200 | |
| Victoria Stewart, Director of Investor Relations and Communications | info@veronapharma.com | |
| Argot Partners (US Investor Enquiries) | Tel: +1-212-600-1902 verona@argotpartners.com | |
| Kimberly Minarovich / Michael Barron | ||
| Optimum Strategic Communications (International Media and European Investor Enquiries) | Tel: +44 (0)203 950 9144 verona@optimumcomms.com | |
| Mary Clark / Karl Hard / Elakiya Rangarajah |
About Ensifentrine
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 also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses.
Ensifentrine has demonstrated statistically significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease (“COPD”). In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD 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 subjects 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 is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine 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, statements regarding the development of ensifentrine and the progress and timing of clinical trials and data, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.
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, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, 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; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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.
FAQ
What is the significance of Verona Pharma's study on fluconazole and ensifentrine?
When are the top-line results for ensifentrine expected?
What is ensifentrine used for?
What clinical trials is Verona Pharma conducting?
What role does fluconazole have in the study?
