Compositions and methods for treating diabetes, hypertension and hypercholesterolemia
Inventors
THAI, NGOC • POLLETT, JONATHAN
Assignees
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Publication Number
US-11612637-B2
Publication Date
2023-03-28
Expiration Date
Abstract
The present invention provides a pharmaceutical formulation comprising a therapeutically effective amount of a polypeptide corresponding to SEQ ID No. 2 and uses thereof for treating at least one of diabetes, hyperglycemia, hypercholesterolemia, and hypertension in a subject.
Core Innovation
The invention relates to pharmaceutical compositions comprising a therapeutically effective amount of a polypeptide consisting of the amino acid sequence according to SEQ ID NO:2, which is derived from 40S ribosomal protein S2 (RPS2). The polypeptide is provided as purified/synthetic therapeutics and in formulations for use in treating diabetes/hyperglycemia and related metabolic disorders.
The disclosed compositions address the need for therapeutics capable of treating diabetes/hyperglycemia and associated metabolic dysfunctions such as hypercholesterolemia and hypertension/metabolic syndrome. The disclosure reports unexpected multi-parameter efficacy in animal models, including normalization of fasting blood glucose, reduction of HbA1c and glucagon, improvement of insulin resistance, suppression of hepatic glucose production, and lowering of blood pressure and cholesterol.
Comparative activity findings indicate that C-terminus fragments retain therapeutic activity, while N-terminal fragments do not. The compositions are reported to show oral and IV activity, with detectable serum levels and no hypoglycemia in non-diabetic rats, along with no adverse creatinine/ALT changes at the tested doses.
Claims Coverage
The independent claim covers a pharmaceutical composition defined by a specific polypeptide sequence (SEQ ID NO:2) and a blood glucose lowering endpoint below 200 mg/dL. Three dependent inventive features refine administration route, formulation components, and therapeutic indications.
SEQ ID NO:2 polypeptide with glucose-lowering endpoint
A pharmaceutical composition comprising a therapeutically effective amount of a polypeptide consisting of the amino acid sequence according to SEQ ID NO:2, wherein the therapeutically effective amount is sufficient to lower blood glucose level in a subject to less than 200 mg/dL.
Oral or parenteral suitability
The pharmaceutical composition of the independent claim is suitable for oral administration or parenteral administration.
Pharmaceutically acceptable carrier, diluent, and/or excipient
The pharmaceutical composition further includes one or more pharmaceutically acceptable carriers, diluents, and/or excipients.
Therapeutic treatment of diabetes, hyperglycemia, and hypertension
The pharmaceutical composition is administered to treat diabetes, hyperglycemia, and hypertension in a subject in need.
Overall, the claim set is directed to a composition containing a SEQ ID NO:2 polypeptide at a therapeutically effective amount that lowers blood glucose to less than 200 mg/dL, with dependent claim refinements for oral/parenteral suitability, inclusion of pharmaceutically acceptable formulation components, and use for diabetes/hyperglycemia and hypertension.
Stated Advantages
Lowers blood glucose level in a subject to less than 200 mg/dL.
Reduces HbA1c and glucagon levels.
Improves insulin resistance.
Suppresses hepatic glucose production.
Lowers blood pressure.
Lowers cholesterol.
Demonstrates oral and IV activity.
Detectable serum levels and no hypoglycemia in non-diabetic rats.
No adverse creatinine/ALT changes at tested doses.
Documented Applications
Treatment of diabetes and hyperglycemia.
Treatment of hypercholesterolemia and hypertension/metabolic syndrome.
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