Ph III trial shows Mezzion Pharma's new orphan drug udenafil improved ventricular function

Mezzion Pharma (Kosdaq: 140410) after-hours on Monday announced that analysis of data from its Phase III FUEL trial showed statistically-significant positive results for an important efficacy endpoint, the myocardial performance index, with the news sending the South Korean biotech firm’s shares up 2.4% to 180,300 won by close of trading today.

The myocardial performance index (MPI) is a measure of ventricular systolic and diastolic function as determined by a focused echocardiogram. The change in the MPI was determined by velocities obtained from Doppler assessment of the inflow and outflow of the single functional ventricle. Subjects on udenafil therapy showed a statistically-significant improvement in ventricular performance as measured by MPI (p=0.028) as compared to subjects taking placebo over the same time period.

"This significant finding suggests that udenafil may provide an important benefit in improving or maintaining ventricular performance of the single functioning ventricle in Fontan patients," stated Dr Seong Ho Kim of Sejong Hospital, one of the investigators for the FUEL trial.