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news.Mezzion Pharma has initiated a clinical program to evaluate the use of udenafil to treat adolescents who have undergone the Fontan surgical palliation for single ventricle heart defects.
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The clinical program will follow protocols developed by a subcommittee made up of representatives of the Pediatric Heart Network (PHN), a multi-center clinical research network funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
The studies, which will be led by PHN researchers, will assess the improvement in certain acute and chronic symptoms in adolescents who had the Fontan procedure earlier in life.
The Fontan operation is the final surgery in the strategy of staged palliation for children born with congenital heart defects resulting in functional single-ventricle physiology. Fontan patients have a significantly shortened life span, often not surviving past the third or fourth decade of life, mainly due to deteriorating ventricular performance and increasing pulmonary vascular resistance.
PDE5 inhibitors have demonstrated utility in reducing pulmonary vascular resistance and improving ventricular performance in other types of patients. Those characteristics make PDE5 inhibitors, especially a long acting compound such as udenafil, an attractive potential therapy for the Fontan population in which cardiac output is limited by the absence of a sub-pulmonary ventricle.
A medication capable of allowing for more efficient transit of blood through the pulmonary vascular bed could allow for improvement in cardiac preload, and therefore improved cardiac output for any given level of systemic venous pressure.
Mezzion Pharma has filed an Investigational New Drug Application (IND) with the FDA and has initiated the first trials in adolescents. There are approximately 19,000 Fontan patients in the US and the company expects that the use of udenafil in such patients for the purpose outlined above will be eligible for orphan-drug designation.
Mr. Dean Park, Chairman, Mezzion Pharma, commented that "We are extremely pleased to collaborate with the PHN in a combined effort to improve the quality of life and lifespan of these adolescents."