Glycemic control using intrinsic factor bound to a vitamin B12 conjugate of a glucagon-like peptide-1 receptor agonist

Inventors

Doyle, RobertBortz, Jonathan D.Hermelin, David S.

Assignees

XERAGENX LLCSyracuse University

Publication Number

US-11771772-B2

Publication Date

2023-10-03

Expiration Date

2036-05-20

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Abstract

The present invention provides compositions and methods for lowering blood glucose. More specifically, the present invention provides compositions comprising a complex comprising IF and B12 conjugated to a peptide comprising a GLP-1 agonist. Advantageously, the composition may be delivered subcutaneously.

Core Innovation

The invention provides compositions and methods for lowering blood glucose by using a complex that combines intrinsic factor (IF) with vitamin B12 (B12) conjugated to a peptide comprising a glucagon-like peptide-1 (GLP-1) receptor agonist. This complex can be delivered subcutaneously or intraperitoneally to subjects in need thereof, resulting in a rapid and significant decrease in blood glucose levels.

The problem addressed by this invention is the need for GLP-1 receptor agonists with improved efficacy and pharmacokinetics, particularly due to the poor bioavailability of these peptides when administered subcutaneously. Current GLP-1 receptor agonists may display limited glycemic control when used alone or even as B12-peptide conjugates without intrinsic factor.

This invention distinguishes itself by complexing the B12-peptide conjugate with intrinsic factor before administration. Through binding of intrinsic factor to B12 conjugated GLP-1 receptor agonists, the composition achieves increased bioavailability and enhanced glucose-lowering activity compared to the conjugate alone. The invention enables the production and use of such complexes for lowering blood glucose and treating diabetes mellitus, including both type 1 and type 2 diabetes.

Claims Coverage

There is one independent claim in this patent, focusing on a method for lowering blood glucose using a specific pharmaceutical composition. The following inventive features are extracted from the claim.

Administration of intrinsic factor complexed with a B12 conjugate containing a GLP-1 receptor agonist

A method comprising subcutaneously or intraperitoneally administering to a subject an effective amount of a pharmaceutical composition. The composition contains intrinsic factor (IF) complexed with a conjugate that includes vitamin B12 or an analog of B12, which is conjugated to a peptide comprising a glucagon-like peptide-1 (GLP-1) receptor agonist.

The claim coverage centers on the specific method of using an intrinsic factor and B12-peptide conjugate complex, administered subcutaneously or intraperitoneally, to lower blood glucose.

Stated Advantages

Enables a rapid and significant drop in glucose levels following administration relative to a peptide conjugated to B12 alone.

Increases bioavailability of the GLP-1 receptor agonist when complexed with intrinsic factor compared to the peptide or B12-peptide conjugate alone.

May allow for subcutaneous delivery of GLP-1 receptor agonists with improved efficacy.

Provides a method that can mitigate the effect of TCII sequestration of a B12 conjugate after administration.

Potential mitigation of nausea side effects associated with incretin hormone use, while maintaining glucose control.

Documented Applications

Lowering blood glucose in a subject following administration of a pharmaceutical composition comprising a complex of intrinsic factor and a B12 conjugate of a GLP-1 receptor agonist.

Treatment of diabetes mellitus in subjects, including type 1 and type 2 diabetes.

Use in humans, livestock animals, companion animals, laboratory animals, and zoological animals for glycemic control.

Mitigating the effect of TCII sequestration of a B12 conjugate by complexing with intrinsic factor before administration.

Potential reduction of nausea associated with exendin-4 therapy via B12 conjugation.

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