Mr. YT Song
Tel: +82 2 560 8011
Mezzion Pharma announces positive results from the Fontan Udenafil Exercise Longitudinal (FUEL) Trial, in adolescents with single ventricle heart disease who have undergone the Fontan procedure.
Seoul, Korea, July 30, 2019 – Mezzion Pharma Co. Ltd. today announced that top line data from the Phase 3 FUEL trial, which was designed to evaluate the safety and efficacy of udenafil for the treatment of certain adolescents with congenital single ventricle heart disease (SVHD), had positive results for key parameters. Although Mezzion is restricted in providing specific data results at the present time due to contractual obligation, the Company is looking forward to publication of the full results in a peer reviewed journal and the presentation of the clinical trial data at a major scientific meeting later this year.
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 view of these results from the FUEL trial and the safety data collected about the drug candidate over other clinical studies, 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 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 Pharma Co. Ltd.
Mezzion Pharma is a publicly-listed biotech company in Korea focusing on the development of new drugs.
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.