Mezzion Pharma Co.,Ltd. Announces Top Line Data from FUEL Will Be Presented at the American Heart Association, Late Breaking Scientific Sessions, in Philadelphia, PA, November 17, 2019
November 04, 2019 at 09:00 am EST
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Mezzion Pharma Co. Ltd. announced that on November 17, 2019, Dr. David Goldberg, Children's Hospital of Philadelphia ("CHOP"), will present the results of Mezzion's landmark FUEL Phase 3 Clinical Trial. The FUEL Trial was designed to evaluate the safety and efficacy of udenafil for the treatment of certain adolescents with congenital single ventricle heart disease (SVHD) who have undergone Fontan palliation. Dr. Goldberg's presentation is scheduled at 10:45 am EST at the American Heart Association ("AHA"), Scientific Sessions, Late-Breaking Science, in Philadelphia, Pa. 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 http://www.pediatricheartnetwork.org/(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 view of the results from the FUEL Trial and the safety data collected about udenafil, Mezzion Pharma intends to submit a New Drug Application to the U.S. Food and Drug Administration to seek approval for the use of udenafil to treat adolescents with SVHD who have undergone Fontan palliation. In addition to this FUEL trial, Mezzion continues forward in its clinical efforts with the OLE Study, conducted under the auspices of the PHN, that is a long term safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease, and the FALD study, also conducted under the auspices of the PHN, which is measuring the ability of udenafil to impact the effects of Fontan Associated Liver Disease. Mezzion has been under a scientific publication embargo which has restricted Mezzion from providing specific data results due to contractual obligation until this presentation at the AHA, Scientific Sessions, Late-Breaking Science, in Philadelphia, Pa.
Mezzion Pharma Co., Ltd. is a Korea-based company engaged in the pharmaceutical business. The Company focuses on development and manufacture of remedies for erectile dysfunction and benign prostatic hyperplasia. In addition, the Company engages in the development of remedies for portal hypertension (PH), pulmonary arterial hypertension (PAH), overactive bladder (OAB), chronic obstructive pulmonary disease (COPD) and others. The Company has sighed licensing contract with overseas partners, including Warner in America, Valenta in Russia, Nycomed in Mexico and Dr.Falk in Europe. On April 22, 2013, the Company changed its name from Dong-A Pharmtech Co., Ltd. to Mezzion Pharma Co., Ltd.
Mezzion Pharma Co.,Ltd. Announces Top Line Data from FUEL Will Be Presented at the American Heart Association, Late Breaking Scientific Sessions, in Philadelphia, PA, November 17, 2019