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On October 12, Goliath Pharmaceuticals announced that its wholly-owned subsidiary, Ganlay Pharmaceuticals, had approved the FDA's IND for clinical trials to treat non-alcoholic fatty hepatitis (NASH) adaptations.
ASC42 is a new, highly effective nonsteroidal X-subject (FXR) astigtor developed in-house by Ganlay and expected to be best-in-class.
two NASH animal models, ASC42 showed significant improvements in liver fatty degeneration, inflammation, and fibrosis.
ASC42 is an oral tablet developed using proprietary therapy and stabilizes at room temperature.
also has two clinically-staged drug candidates in its NASH pipeline, ASC40 and ASC41.
ASC40 (TVB-2640) is an oral fatty acid synthase (FASN) inhibitor, phase II. Clinical (FASCINATE-1) data from the United States show that ASC40 (TVB-2640) significantly reduced liver fat content, with a response rate of up to 61% in the 50 mg dose group.
ASC41 is a prescive drug with liver targeting and its active ingredient (ASC41-A) is β THR-A.
ASC42 can be used alone or in federation with ASC40 or ASC41.
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