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Data were presented at the 2021 International Liver Congress.
These analyses show significant correlations between normalization of liver fat and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism.
The new analyses also show that combining ALT response of more than 17 U/L with normalization of liver fat increases the power to predict resolution of NASH.
More than 50% reduction in liver fat content was observed in 69% of the patients in the 28mg EFX group, 100% patients in the 50mg EFX arm, and 93% in the 70mg EFX group at week 12.
Over 70% liver fat reduction was seen in 50%, 53%, and 80% of the patients in the three dose groups.
Only 5% of the patients achieved a liver fat reduction of over 50% or 70% in the placebo arm.
Normalization of liver fat content was reported in 25%, 53%, and 67% of the patients in the three dose groups.
EFX is currently being evaluated in a Phase 2b HARMONY trial in F2/F3 fibrosis patients.
A second Phase 2b trial in patients with Cirrhotic (F4) NASH is planned for the second half of 2021.
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