- Axella Therapeutics AXLA reported interim results from its ongoing global Phase 2b EMMPACT study of AXA1125 in nonalcoholic steatohepatitis (NASH).
- After 24 weeks, Axcella said, all patients taking the high dose of its drug AXA1125 showed a statistically significant improvement in the measurement of liver stiffness (LSM) compared to placebo, achieving 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 beneficial effect in long-term COVID-related fatigue.
- At 12 and 24 weeks, all patients analyzed showed statistically significant improvements in alanine aminotransferase (ALT), indicative of hepatocellular inflammation, Axcella said.
- The improvements were -28.61% (p=0.0183) for the low dose and -36.3% (p=0.0017) for the high dose.
- The results show an improvement in liver 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 top-line 48-week biopsy results in the first half of 2024.
- Price promotion: AXLA stock is up 12.7% to $1.95 during the premarket session last check Thursday.
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