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Pharmaceutical company Gannex Pharma announced today that its candidate drug ASC42 for the treatment of non-alcoholic fatty liver (NASH) research new drug application (IND) has been approved by the FDA.
ASC42 is a new nonsteroidal selective strong-acting nicol X-subject (FXR) agitant.
in two NASH animal models, ASC42 significantly improved liver fat degeneration, inflammation and fibrosis.
Gannex Pharma has two other drug candidates, ASC40 and ASC41, in the clinical phase of its NASH pipeline.
in Phase II clinical trials (FASCINATE-1 studies), oral fatty acid lysase (FASN) inhibitor ASC40 (TVB-2640) has been shown to significantly reduce liver fat levels at a 61% response rate in the 50 mg group.
ASC41 is a liver-targeted pre-drug whose active part (ASC41-A) is β TRS-A.
it is expected that the ASC42 can be used alone or in federation with the ASC40 or ASC41.
Handan He, chief scientific officer of Gannex Pharma, said: "We are pleased that the FDA has approved THED for ASC42 for NASH.
NASH is an increasingly prevalent disease and there is currently no approved treatment.
this is an important milestone that allows us to begin clinical trials this year to meet the medical needs of the treatment NASH."
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