Shares of Axcella Therapeutics (Nasdaq: AXLA) were up almost 20% at $2.07 pre-market, after the US biotech said its experimental treatment for the challenging disease area of non-alcoholic steatohepatitis (NASH) showed statistically-significant improvement in liver stiffness.
The interim analysis of a Phase IIb indicates that administration of AXA1125 over 24 weeks leads to statistically-significant improvements compared to placebo in biomarkers for metabolism, inflammation and fibrosis, underscoring its multi-targeted efficacy.
This interim analysis was pre-planned to be conducted when enrollment reached 30% of the target of 270 subjects with biopsy confirmed stage two or three NASH across all trial arms. Data from this ongoing blinded study included 82 subjects at week 12 and 58 subjects at week 24; approximately half of the subjects have type 2 diabetes mellitus (T2DM).
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