Therapeutic agent for fatty liver disease
Inventors
ANDO, Ayatoshi • KAWANISHI, Ippei • Shiraishi, Seiji • Tanaka, Harumi • Saitou, Yuki
Assignees
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Publication Number
US-12023320-B2
Publication Date
2024-07-02
Expiration Date
Abstract
An object of the present invention is to provide a therapeutic agent for fatty liver diseases. The above object can be achieved by a therapeutic agent for a fatty liver disease, comprising a compound represented by the following formula (1): or a pharmaceutically acceptable salt thereof.
Core Innovation
The patent describes a therapeutic agent for fatty liver disease that comprises a compound represented by formula (1) or a pharmaceutically acceptable salt thereof, including hydrochloride. The therapeutic agent is administered as a therapeutically effective amount to a patient in need of treatment, and the fatty liver disease is selected from non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and metabolic-associated fatty liver disease (MAFLD).
The disclosed therapeutic agent addresses a need for treatment of fatty liver disease in the context of disease progression and symptoms. The patent further provides in vivo evaluation using a high-fat and high-fructose-induced NASH model (FFD) in mice and uses hydrochloride of the compound represented by formula (1) (compound 1).
The evaluation assesses plasma ALT/AST, plasma total cholesterol, liver triglycerides, Sirius red-positive area, and CD68-positive crown-like structures (hCLS). The results report statistically significant improvements, including reduced fibrosis and inflammation, with histopathology supporting reduced steatosis and fibrosis, leading to the conclusion of efficacy in the NASH model.
Claims Coverage
The provided independent claim covers one core inventive concept with two inventive features: administering a therapeutically effective amount of a compound represented by formula (1) or a pharmaceutically acceptable salt, and limiting the fatty liver disease to NAFLD, NASH, or MAFLD.
Treating fatty liver disease by administering a formula (1) compound or pharmaceutically acceptable salt
A method for treating a fatty liver disease by administering to a patient in need a therapeutically effective amount of a compound represented by formula (1) or a pharmaceutically acceptable salt thereof.
Fatty liver disease selected as NAFLD, NASH, or MAFLD
The method is characterized in that the fatty liver disease is selected from non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and metabolic-associated fatty liver disease (MAFLD).
Overall claim coverage is centered on a treating method for fatty liver disease in which a patient in need receives a therapeutically effective amount of a compound represented by formula (1) or a pharmaceutically acceptable salt, with the fatty liver disease limited to NAFLD, NASH, or MAFLD.
Stated Advantages
Improvement in disease endpoints in the high-fat and high-fructose-induced NASH (FFD) mouse model, including reduced fibrosis and inflammation.
Histopathology supports reduced steatosis and fibrosis.
Documented Applications
Treatment of fatty liver disease in patients in need, where the fatty liver disease is selected from NAFLD, NASH, and MAFLD.
In vivo evaluation in a high-fat and high-fructose-induced NASH model (FFD) in mice using hydrochloride of the compound represented by formula (1), with assessment of plasma ALT/AST, plasma total cholesterol, liver triglycerides, Sirius red-positive area, and CD68-positive crown-like structures (hCLS).
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