Axcella TherapeuticsAXLAreported 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.
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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