After independent review, study continues as planned with enrollment on track for completion in 2026
SEOUL, South Korea and FORT LEE, N.J., June 5, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) today announced the results of a planned independent, blinded statistical review of its ongoing global confirmatory Phase 3 FUEL-2 study evaluating udenafil, its investigational therapy for single ventricle heart disease with Fontan circulation.
After 50% of the planned study population completed the study's 26-week treatment period, an independent assessment was conducted to determine whether an increase in sample size would be required to maintain the study's planned statistical assumptions.
The independent review determined that no increase in sample size was required and recommended that the study continue as planned with the enrollment of 436 patients. Moreover, no changes were recommended to the study design, primary endpoint, statistical analysis plan, or projected study timelines.
"We believe the successful completion of this independent review marks an important milestone for the FUEL-2 program," said Dean Park, Chairman and CEO of Mezzion Pharma. "We remain focused on advancing udenafil toward becoming the first approved therapy specifically indicated for patients with single ventricle heart disease with Fontan circulation."
Mezzion Pharma has now completed all major planned statistical review milestones prior to topline data.
Single ventricle heart disease with Fontan circulation is a rare and serious form of congenital heart disease associated with significant long-term complications. Despite advances in surgical care, there are currently no approved therapies specifically indicated for this rare disease with unmet medical need.
About Mezzion Pharma
Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) is a late-stage biopharmaceutical company focused on developing therapies for rare cardiovascular and renal diseases. Its lead program, udenafil, is being developed as a potential first therapy specifically indicated for patients with Fontan circulation. Udenafil is an investigational product and has not been approved by any regulatory authority. Mezzion conducts its U.S. operations through its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc. For more information, visit mezzion.com or FUEL2Study.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding future events and the future performance of Mezzion Pharma, including statements regarding clinical development timelines, regulatory activities, potential approval of udenafil, and anticipated study outcomes. Actual results may differ materially from those expressed or implied by these forward-looking statements. Mezzion undertakes no obligation to update any forward-looking statements except as required by applicable law.
Media Contacts:
John Presser, EVP, CBO: john.presser@mezzion.com
Mr. Sung-Il Noh, CFO: sung-il.noh@mezzion.com
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SOURCE Mezzion Pharma Co., Ltd.
