Treatment of NAFLD and NASH
Inventors
Roberts, Brian • Wang, Xueyan • CHOI, YUN-JUNG • Karpf, David • Martin, Robert • McWherter, Charles
Assignees
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Publication Number
US-10722483-B2
Publication Date
2020-07-28
Expiration Date
Abstract
Treatment of NAFLD and NASH by therapy with MBX-8025 or an MBX-8025 salt.
Core Innovation
The invention provides a method for treating non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) by administering seladelpar or a salt thereof, including MBX-8025 (seladelpar) and MBX-8025 L-lysine dihydrate salt. The method is directed to reducing alkaline phosphatase (ALP) or γ-glutamyl transpeptidase (GGT) in a subject having NAFLD or NASH, using a therapeutically effective amount of the specified seladelpar form(s).
The document characterizes MBX-8025 as an orally active, potent PPARδ agonist, including a salt form such as L-lysine dihydrate. Clinical evidence cited in the document indicates that MBX-8025 L-lysine reduces lipid markers and significantly lowers ALP and GGT, linking seladelpar-based therapy to biochemical improvements relevant to NAFLD/NASH assessments.
The document further states that treatment with MBX-8025 (seladelpar) is expected to improve NAFLD/NASH endpoints including hepatic fat by MRI, transaminases, inflammatory markers/cytokines, and glycemic parameters. Overall, the core concept is using orally administered seladelpar or specified salts to reduce ALP and/or GGT in NAFLD or NASH subjects while targeting broader hepatic and metabolic endpoints.
Claims Coverage
The provided independent claims cover reducing ALP or GGT in NAFLD or NASH subjects via administration of seladelpar or salts, including oral administration of seladelpar L-lysine dihydrate salt. Across the independent claims, the inventive features emphasize the NAFLD/NASH indication, the enzyme target, and the specific seladelpar form and administration mode.
Reducing ALP or GGT in NAFLD or NASH by administering seladelpar or a salt thereof
A method for reducing alkaline phosphatase (ALP) or γ-glutamyl transpeptidase (GGT) in a subject having NAFLD or NASH, comprising administering a therapeutically effective amount of seladelpar or a salt thereof to the subject.
Reducing ALP or GGT in NAFLD or NASH by orally administering seladelpar or a salt thereof
A method for reducing alkaline phosphatase (ALP) or γ-glutamyl transpeptidase (GGT) in a subject having NAFLD or NASH, comprising orally administering a therapeutically effective amount of seladelpar or a salt thereof to the subject.
Reducing ALP or GGT in NAFLD or NASH by orally administering seladelpar L-lysine dihydrate salt
A method for reducing alkaline phosphatase (ALP) or γ-glutamyl transpeptidase (GGT) in a subject having NAFLD or NASH, comprising orally administering a therapeutically effective amount of seladelpar L-lysine dihydrate salt to the subject.
The claim set centers on using seladelpar and salts to reduce ALP and/or GGT in NAFLD or NASH, with independent coverage of general administration, oral administration, and a specific oral salt form.
Stated Advantages
Significantly lowers ALP and GGT.
Reduces lipid markers.
Expected to improve NAFLD/NASH endpoints including hepatic fat by MRI, transaminases, inflammatory markers/cytokines, and glycemic parameters.
Documented Applications
Treatment of a subject having non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) by administering seladelpar or a salt thereof to reduce alkaline phosphatase (ALP) or γ-glutamyl transpeptidase (GGT).
Use of MBX-8025 (seladelpar) or MBX-8025 L-lysine dihydrate salt as an orally active therapy, with evaluation of hepatic and metabolic endpoints including hepatic fat by MRI and inflammatory markers/cytokines.
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