Shots:

• The US FDA has granted the BTD to efruxifermin for NASH. The designation was based on the P-IIb (HARMONY) study of EFX (qw, SC, 50/28mg) vs PBO in 128 patients with biopsy-confirmed pre-cirrhotic NASH, F2-F3
• The trial met its 1EPs & 2EPs i.e., EFX (50/28mg) showed a ≥1 stage improvement in fibrosis without worsening of NASH (41%/39% vs 20%); NASH resolution without worsening of fibrosis (76%/47% vs 15%), fibrosis improvement & resolution of NASH (41%/29% vs 5%) along with an improvement in liver fat, liver enzymes, noninvasive fibrosis markers, glycemic control, lipoproteins & body weight
• The therapy was well-tolerated. The P-IIb (SYMMETRY) study results are expected in H2’23 & 12wk. of an expansion cohort of the same study in H1’23

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