Investigational NASH Tx Fast Tracked by FDA
Nimbus Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation to NDI-010976 for the treatment of non-alcoholic steatohepatitis (NASH).
NASH, a serious chronic liver disease caused by excessive fat accumulation in the liver, affects about 5-10% of adults in the United States. There are currently no FDA-approved treatments for NASH or related fatty-liver disorders.
Nimbus is in preparation to initiate a Phase 2 clinical study for NDI-010976 in the first half of this year. Results of the completed Phase 1 study will be presented at the upcoming European Association for the Study of Liver Diseases (EASL) meeting in April 2016.
NDI-010976 is a high-potency, liver-targeted allosteric inhibitor of acetyl-CoA carboxylase (ACC), a pair of enzymes that catalyze a very early biochemical step in the synthesis of endogenous fatty acids. Inhibition of ACC results in prevention of lipogenesis and stimulation of mitochondrial beta-oxidation in certain tissues.
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