A trend was observed for the primary endpoint of fibrosis (scarring) improvement at 36 weeks, with 22% and 24% of the 28mg (p-value of 0.38) and 50mg (p-value of 0.28) EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14% for placebo.

In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH — from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo. 

Statistically significant rates of NASH resolution in 63% and 60% of patients at week 36 were observed for the 28mg and 50mg EFX-treated groups, respectively, compared with 26% for placebo.

Statistically significant improvements were also observed for both EFX groups in non-invasive liver injury and fibrosis markers, insulin sensitization, and lipoproteins.

EFX was reported to be generally well-tolerated. Diarrhea, nausea, increased appetite, and injection site erythema were the most frequent treatment-emergent adverse events related to the drug.

Price Action: AKRO shares are down 56.3% at $21.20 during the premarket session on the last check Tuesday.