Verona Pharma Reports TQT Study Successfully Demonstrated No Clinically Relevant Effect on Cardiac Conduction
London and Raleigh, N.C., December 16, 2021 – 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.”
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
- 400 mg of oral moxifloxacin
- Primary endpoint: Placebo-corrected change from baseline in QTcF (ΔΔQTcF).