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-10342770-B2
Publication Date
2019-07-09
Expiration Date
Abstract
Treatment of NAFLD and NASH by therapy with MBX-8025 or an MBX-8025 salt.
Core Innovation
The invention relates to a method for reducing cirrhosis or fibrosis in a subject having non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). It comprises administering a therapeutically effective amount of seladelpar or a salt thereof, including seladelpar L-lysine dihydrate salt. The approach is framed around using seladelpar as a PPARδ agonist for treatment of NAFLD and NASH.
The problem being addressed is the unmet need in connection with NAFLD and NASH. The background links NAFLD and NASH to metabolic syndrome, and positions PPARδ agonism via MBX-8025 (seladelpar) as the therapeutic concept. The invention further describes characterization of MBX-8025 as seladelpar, including chemical identity or structure, and its oral bioactivity and PPARδ potency/selectivity.
The disclosure summarizes supportive effects from prior clinical/nonclinical work, including reductions in apoB/LDL/triglycerides and hsCRP, and improvements in glycemic parameters. The therapeutic rationale is directed to reductions in hepatic fat and inflammation, and ultimately to reducing cirrhosis or fibrosis in subjects with NAFLD or NASH. An example framework is provided using oral dosing and monitoring of hepatic fat and liver outcomes.
Claims Coverage
The document provides two independent claims that are both directed to reducing cirrhosis or fibrosis in subjects with NAFLD or NASH using seladelpar (or salts) administered orally, including specifically seladelpar L-lysine dihydrate salt in one independent claim. The inventive features focus on the therapeutic target, the active agent, and the administration route.
Reducing cirrhosis or fibrosis in NAFLD or NASH by administering seladelpar or a salt thereof
A method for reducing cirrhosis or fibrosis in a subject having non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), comprising administering a therapeutically effective amount of seladelpar or a salt thereof to the subject.
Reducing cirrhosis or fibrosis in NAFLD or NASH by orally administering seladelpar or a salt thereof
A method for reducing cirrhosis or fibrosis in a subject having non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), comprising orally administering a therapeutically effective amount of seladelpar or a salt thereof to the subject.
Reducing cirrhosis or fibrosis by orally administering seladelpar L-lysine dihydrate salt
A method for reducing cirrhosis or fibrosis in a subject having non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), comprising orally administering a therapeutically effective amount of seladelpar L-lysine dihydrate salt to the subject.
Across the independent claims, the core claim coverage is methods that reduce cirrhosis or fibrosis in NAFLD/NASH subjects using therapeutically effective amounts of seladelpar (or salts), with one independent claim explicitly limited to oral administration and another limited to seladelpar L-lysine dihydrate salt.
Stated Advantages
Reducing cirrhosis or fibrosis in subjects having NAFLD or NASH.
Reductions in hepatic fat and inflammation are described as part of the therapeutic rationale.
Reductions in apoB/LDL/triglycerides and hsCRP are described.
Improvements in glycemic parameters are described.
Documented Applications
Treatment of NAFLD and NASH by reducing cirrhosis or fibrosis using seladelpar (MBX-8025) or its salts, including seladelpar L-lysine dihydrate salt.
An example framework is described using oral dosing and monitoring hepatic fat by MRI and liver outcomes including liver biopsy.
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