• Axcella Therapeutics AXLA reported interim results from its ongoing global Phase 2b EMMPACT study of AXA1125 for nonalcoholic steatohepatitis (NASH).
  • At 24 weeks, Axcella said all patients taking the high dose of its drug, AXA1125, showed statistically significant improvement in liver stiffness measurement (LSM) compared to placebo, coming in at a p-value of 0.0096 with an absolute change in LSM at -4.07 kilopascals (kPa). 
  • The low-dose arm did not reach statistical significance with -2.01 kPa and a p-value of 0.0992. Positive changes in liver stiffness are correlated with improvement in fibrosis.
  • Related: Axcella’s NASH Candidate Shows Favorable Action In Long COVID-Related Fatigue.
  • At 12 and 24 weeks, all patients analyzed were shown to have statistically significant improvements in alanine aminotransferase (ALT), indicative of liver cell inflammation, Axcella said. 
  • The improvements came in at -28.61% (p=0.0183) for the low dose and -36.3% (p=0.0017) for high dose.
  • Findings demonstrate improvement in hepatic fat as measured by MRI-PDFF.
  • All subjects experienced significantly greater changes in MRI-PDFF at 12 weeks but were not statistically significant in the small number of subjects at 24 weeks.
  • The company expects to report the topline, 48-week biopsy results in the first half of 2024.
  • Price Action: AXLA stock is up 12.7% at $1.95 during the premarket session on the last check Thursday.

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