GENFIT Announces Discontinuation of its VS-01 Program in ACLF: VS-01 Development Refocused on UCD [Yahoo! Finance]
GENFIT S.A. - American Depositary Shares (GNFT)
Company Research
Source: Yahoo! Finance
Euronext: GNFT) , a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its decision to discontinue its VS-01 program in ACLF (Acute-on-Chronic Liver Failure), and reprioritize the development of VS-01 on UCD (Urea Cycle Disorder). GENFIT's decision follows the occurrence of a peritonitis case reported as Serious Adverse Event (SAE) in the UNVEIL-IT® clinical trial evaluating VS-01 in patients with ACLF grades 1, 2 or 3a and ascites and subsequent review and feedback from the independent Data Monitoring Committee (iDMC). The committee concluded that the trial could continue but required additional data and monitoring. Despite the possibility to move ahead with the study, GENFIT decided – after considering the target population's clinical profile as well as the implications of this type of safety signal for the benefit/risk ratio of VS-01 in this indication – to discontinue both UNVEIL-IT® and the proof
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