Verona Pharma Reports TQT Study Successfully Demonstrated No Clinically Relevant Effect on Cardiac Conduction
Verona Pharma has successfully completed a thorough QT study for its product candidate ensifentrine, showing no adverse effects on cardiac conduction in healthy individuals. This study is essential for the NDA submission for ensifentrine, aimed at treating COPD. The results will support the ongoing Phase 3 clinical trial program, ENHANCE, with expected data reporting in 2022. Ensifentrine, if approved, could become the first treatment combining bronchodilator and anti-inflammatory properties for respiratory diseases.
- Ensifentrine met all safety objectives in the TQT study.
- No clinically relevant changes in cardiac conduction were observed.
- Study results support planned NDA submission for ensifentrine.
- The ongoing ENHANCE Phase 3 program is progressing as planned.
- None.
Study Supports Ongoing Phase 3 Program and Planned NDA Submission
LONDON and RALEIGH, N.C., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces ensifentrine met all safety objectives in a thorough QT (“TQT”) study designed to evaluate effects, if any, of ensifentrine on cardiac conduction in healthy individuals. No clinically relevant changes in measures of cardiac conduction including QTcF, PR and QRS intervals were observed with either 3 mg or 9 mg inhaled ensifentrine dose at any time point over 24 hours.
The U.S. Food and Drug Administration (“FDA”) requires a TQT study to support most New Drug Applications for potential new medications. The protocol was reviewed by the FDA prior to commencing the study, and these results will support the planned submission for ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).
David Zaccardelli, Pharm. D., President and CEO of Verona Pharma said: “These data bring us a step closer to a planned NDA submission for ensifentrine. We continue to evaluate the first-in-class treatment in our ongoing ENHANCE Phase 3 clinical trial program in COPD and expect to report results in 2022.”
Study Design
The randomized, double-blind, crossover TQT study evaluated the effect of therapeutic and supratherapeutic doses of nebulized ensifentrine on measures of cardiac conduction compared with placebo in healthy volunteers. Moxifloxacin was included as a positive control.
- Population: 32 healthy volunteers
- Dose/Duration: Participants received the following treatments as a single dose in separate periods in random sequence:
- 9 mg of nebulized ensifentrine
- 3 mg of nebulized ensifentrine
- placebo
- 400 mg of oral moxifloxacin
- Primary endpoint: Placebo-corrected change from baseline in QTcF (ΔΔQTcF).
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)203 882 9621 verona@optimumcomms.com |
| Mary Clark / Stella Lempidaki / Zoe Bolt |
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 TQT study results supporting the planned submission of ensifentrine for the maintenance treatment of COPD, the progress and timing of clinical trials and data, the potential of ensifentrine as a first-in-class 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 September 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.
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