Mezzion Pharma's new orphan drug udenafil improved ventricular function measured by myocardial performance index (MPI) in adolescents with congenital single ventricle heart disease (SVHD) - Further results from the pivotal 400-subject Phase 3 FUEL Trial

SEOUL, South Korea, May 18, 2020 /PRNewswire/ -- Mezzion Pharma Co. Ltd. today announced that analysis of data from its Phase 3 FUEL trial showed statistically significant positive results for an important efficacy endpoint, the myocardial performance index.

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, who is one of the investigators for the FUEL trial.

Professor Gi Beom Kim, also a principal investigator for the FUEL trial at Seoul National University Hospital, further states, "This significant, positive effect in ventricular performance in addition to the improvement in exercise capacity suggest that udenafil will be a beneficial new pharmacotherapy for SVHD where at present there are no approved drugs to treat these patients."

This positive MPI finding resulting from udenafil therapy together with previously published data showing statistically significant improvement in exercise capacity as measured by oxygen consumption at the ventilatory anaerobic threshold (VO₂ at VAT), statistically significant improvements in work rate at VAT and ventilatory equivalents of carbon dioxide at VAT (VE/VCO₂) in SVHD patients resulting from treatment with udenafil will collectively be the clinical basis for the planned New Drug Application that Mezzion plans to submit to the FDA shortly.  Being designated as an "orphan indication", Mezzion expects that this NDA will be given a priority review by the FDA. 

Mezzion Pharma has filed U.S. and PCT patent applications that cover this important MPI improvement for SVHD patients who are treated with udenafil.  Mezzion has previously filed applications for patent protection covering the statistically significant improvements in exercise capacity as measured by oxygen consumption at the ventilatory anaerobic threshold (VO₂ at VAT), work rate at VAT, and ventilatory equivalents of carbon dioxide (VE/VCO₂) at VAT in SVHD patients treated with udenafil.  This new MPI patent application adds to a global family of patents issued to and patent applications filed by Mezzion Pharma that are directed to these unique and important improvements in the treatment of SVHD patients, including SVHD patients with Fontan physiology, with udenafil.

The FUEL Trial is a study in 400 male and female adolescents with a single functional ventricle who had previously undergone Fontan surgical palliation. Study participants were drawn from a total of 30 Pediatric Heart Network (PHN) and auxiliary sites throughout the U.S., Canada, and Korea. The PHN is funded by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.

In addition to this FUEL trial, Mezzion continues forward in its clinical efforts with the FALD study, also conducted under the auspices of the PHN.  The FALD study is designed to measure the ability of udenafil to impact the effects of Fontan Associated Liver Disease which is prevalent in virtually all SVHD subjects with Fontan physiology. 

Mezzion Pharma Co. Ltd.

Mezzion Pharma is a Korea-headquartered biotech company listed and traded on KOSDAQ Exchange.

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.

Contact:

Dr. James Yeager
COO
Mezzion Pharmaceuticals, Inc
Deerfield, Illinois 60015
James.Yeager@mezzion.com

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