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ACT300 is a long-acting recombinant protein candidate developed by Amoytop Biotech for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD). It functions as an agonist of the Fibroblast Growth Factor 21 (FGF21) pathway. FGF21 is a metabolic hormone that plays a critical role in regulating lipid and glucose metabolism, enhancing insulin sensitivity, and reducing hepatic fat accumulation and inflammation. ACT300 utilizes Amoytop's proprietary Y-shaped polyethylene glycol (YPEG) technology to extend the half-life of the protein, allowing for less frequent subcutaneous administration while maintaining therapeutic efficacy. The drug is currently being evaluated in Phase 1 clinical trials to assess its safety, tolerability, and preliminary efficacy in patients with MASLD and metabolic dysfunction-associated steatohepatitis (MASH).
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