Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease
Inventors
Baron, Alain D. • Kim, Dennis • Maggs, David G. • Wintle, Matthew
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8389472-B2
Publication Date
2013-03-05
Expiration Date
Abstract
The present invention relates generally to the novel use of incretin compounds (ICs) and amylinomimetic compounds to treat, prevent, or ameliorate a variety of metabolic conditions or diseases.
Core Innovation
The disclosed invention relates to treating metabolic diseases, including nonalcoholic steatohepatitis and nonalcoholic fatty liver disease, in a human in need thereof. The treatment uses incretin compounds and/or amylinomimetics, with exendin-4 and exenatide highlighted as exemplary incretin compounds and as part of the therapeutic approach.
The patent characterizes incretin compounds in the context of GLP-1 and GIP and describes amylinomimetics in relation to amylin, including mention of amylin/sCT hybrids. It frames the unmet need in hyperglycemia-associated conditions and positions the exendin-4/exenatide approach as targeting nonalcoholic steatohepatitis and nonalcoholic fatty liver disease.
The patent associates treatment with changes in liver injury biomarkers, including alanine aminotransferase and aspartate aminotransferase, and reports supporting findings from long-term exenatide studies. The summary indicates reductions in ALT and AST, particularly in subjects with elevated baseline ALT, together with glycemic and weight improvements, consistent with treating nonalcoholic steatohepatitis and nonalcoholic fatty liver disease using exendin-4.
Claims Coverage
The independent claims cover treating nonalcoholic steatohepatitis and nonalcoholic fatty liver disease by administering exendin-4 as the active therapeutic. Across the independent claims, the core inventive content is centered on exendin-4 administration, with route limitations and optional combination therapy.
Subcutaneous exendin-4 for nonalcoholic steatohepatitis
A method for treating nonalcoholic steatohepatitis in a human in need thereof comprising subcutaneously administering to the human a therapeutically effective amount of exendin-4 to treat the nonalcoholic steatohepatitis in the human.
Exendin-4 therapy for nonalcoholic steatohepatitis subject treatment
A method for treating nonalcoholic steatohepatitis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of exendin-4 to treat the nonalcoholic steatohepatitis in the subject.
Exendin-4 therapy for nonalcoholic fatty liver disease
A method for treating nonalcoholic fatty liver disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of exendin-4 to treat the nonalcoholic fatty liver disease in the subject.
Subcutaneous exendin-4 for nonalcoholic fatty liver disease
A method for treating nonalcoholic fatty liver disease in a human in need thereof comprising subcutaneously administering to the human a therapeutically effective amount of exendin-4 to treat the nonalcoholic fatty liver disease in the human.
Overall, the claim coverage centers on treating nonalcoholic steatohepatitis and nonalcoholic fatty liver disease by administering exendin-4 at a therapeutically effective amount, with independent claim coverage spanning both human and subject formulations and specific inclusion of subcutaneous administration in the human/subcutaneous variants. Dependent refinements further include parenteral delivery options, plasma concentration or time maintenance constraints for exendin-4, and optional addition of a dipeptidyl peptidase-IV inhibitor, metformin, and/or a sulfonylurea.
Stated Advantages
Improves hepatic injury biomarkers ALT/AST in the described clinical context.
Improves glycemic control in the described clinical context.
Improves weight in the described clinical context.
Reductions in liver injury biomarkers, including ALT and AST, particularly in subjects with elevated baseline ALT.
Glycemic improvements.
Weight improvements.
Documented Applications
Treatment of nonalcoholic steatohepatitis in a human subject by administering a therapeutically effective amount of exendin-4, including subcutaneous administration.
Treatment of nonalcoholic fatty liver disease in a human subject by administering a therapeutically effective amount of exendin-4, including subcutaneous administration.
Clinical evidence in type 2 diabetes patients with hepatic injury biomarkers ALT/AST, with attention to elevated baseline ALT, alongside glycemic control and weight outcomes.
Treating nonalcoholic steatohepatitis in a human or subject in need thereof using exendin-4, including subcutaneous administration variants.
Treating nonalcoholic fatty liver disease in a human or subject in need thereof using exendin-4, including subcutaneous administration variants.
Interested in licensing this patent?