The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to cirrhosis, liver cancer, and other life-threatening conditions. NASH stems from multifactorial systemic dysregulation of the pathways associated with metabolism, inflammation, and fibrosis. Axcella’s new therapy, AXA1125, is an orally ingested multitargeted candidate that has potential to treat NASH and other serious liver diseases. Axcella Therapeutics is a clinical-stage biotech company that develops therapies to treat serious diseases using endogenous metabolic modulator (EMM) compositions.

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