Inventiva announces positive results of clinical thorough QT study conducted with lanifibranor
Daix (France), Long Island City (New York, United States), December 6, 2021 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced the results of a clinical thorough QT/QTc study demonstrating the safety of lanifibranor on cardiac electrical activity.
The assessment of lanifibranor on cardiac repolarization was conducted in accordance with Food and Drug Administration guidance (FDA) in a phase I double-blind clinical trial to be included in the NDA package of lanifibranor for the treatment of NASH. The clinical trial enrolled 217 healthy subjects who were randomized into four arms, placebo, lanifibranor 1200mg/day (anticipated maximal therapeutic dose), lanifibranor 2400mg/day (supra-therapeutic dose), and moxifloxacin 400mg/day (positive control). The primary electrocardiogram (ECG) endpoint was monitored during the first 24hrs and on the last day of treatment.
Repeated daily administration of lanifibranor dosed up to 2 fold higher than the anticipated maximal therapeutic dose had no effect on cardiac electrical activity as shown by achieving the pre-specified primary endpoint of demonstrating no prolongation of the QT interval in healthy subjects. Lanifibranor was well tolerated at both dose levels.Download PDF