Mezzion Pharma Co. Ltd. announces the presentation of data from its pivotal clinical trial for its new orphan drug for the treatment of adolescents with single ventricle heart disease. The top line data from the FUEL trial, which was designed to evaluate the safety and efficacy of udenafil for the treatment of SVHD adolescents, showed that subjects taking udenafil over a 6-month period had a significant improvement in exercise capacity as measured by oxygen consumption at the ventilatory anerobic threshold (VO2 at VAT). Work rate at VAT and ventilatory equivalents of carbon dioxide at the VAT (VE/VCO2) were likewise improved. While peak VO2 also improved, the data did not reach statistical significance. VO2 at VAT measures the level of oxygen consumption at which one changes from aerobic to anaerobic activity, a clinically relevant level of exertion that is typical of what is encountered in routine exercise activity. Work rate measures the power (watts) generated at the VAT while VE/VCO2 is an index comparing the volume of CO2 with the total respiratory volume. All of these measures demonstrated statistically significant improvement in the udenafil treated group compared to the placebo treated group. The PHN is funded by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health. In addition to the pivotal FUEL trial, Mezzion continues forward in its clinical program in partnership with the PHN with a long-term study to evaluate the safety of udenafil (FUEL-OLE Study) ClinicalTrials.gov Identifier: NCT03013751) and a study to evaluate the effect of treatment on Fontan-associated Liver Disease (FALD study). Because of the elevated central venous pressure, liver fibrosis, which can lead to liver cirrhosis, is prevalent in almost all Fontan subjects starting at a very early age. (ClinicalTrials.gov Identifier: NCT03430583).