Verona Pharma plc (NASDAQ: VRNA) disclosed that the TQT study successfully showed no clinically relevant effect on cardiac conduction. The company confirmed that Ensifentrine fulfills all safety objectives in a TQT study intended to assess effects if any, of Ensifentrine on cardiac conduction in healthy individuals.
The randomized, double-blind, crossover TQT study assessed the effect of therapeutic and supratherapeutic doses of nebulized Ensifentrine on rates of cardiac conduction compared with placebo in healthy volunteers. Moxifloxacin was incorporated as a positive control. In study 32, healthy individuals were included.
Furthermore, during the study, the volunteers received 9 mg of nebulized Ensifentrine, 3 mg of nebulized Ensifentrine, and 400 mg of oral moxifloxacin as a single dose in separate periods in random sequence. In the study, the company has incorporated Moxifloxacin as a positive control.
In addition, the U.S. FDA demands a TQT study to support most New Drug Applications for potential new medications. The protocol was evaluated by the FDA before the start of the study, and these results will help the proposed submission for Ensifentrine for the upkeep treatment of chronic obstructive pulmonary disease (COPD).
Moreover, Verona Pharma stated that these data bring it a step closer to a scheduled NDA submission for Ensifentrine. The company confirmed that it will continue to assess the first-in-class treatment in its ongoing ENHANCE Phase 3 clinical trial program in COPD and anticipate sharing results in 2022.