Hepion has begun wind-down activities of ASCEND-NASH P-IIb study, to evaluate safety and efficacy of Rencofilstat for 12 mos. to treat non-alcoholic steatohepatitis (NASH) and advanced liver fibrosis
ASCEND-NASH, a P-IIb study (estimated enrolment 336) started in Aug’22 was paused in Apr’23, with 151 randomized patients. Until now, around 80 patients have completed their Day 365 visits and evaluated for safety and efficacy. Additional, 40 patients will provide substantial safety data for evaluation; patients will be added to company’s existing safety database
Rencofilstat received Fast Track designation (FTD) from US FDA for NASH in Nov’21, and Orphan Drug designation (ODD) for HCC in Jun’22
Ref: Hepion Pharmaceuticals | Image: Hepion Pharmaceuticals
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