Methods and compositions for treating NAFLD, hepatic steatosis, and sequelae thereof

A kind of composition, chelate technology, applied in the direction of drug combination, pharmaceutical formula, organic active ingredient etc.

Inactive Publication Date: 2015-09-09
ORAMED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] To date, GLP-1 analogs are only available in injectable form

Method used

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  • Methods and compositions for treating NAFLD, hepatic steatosis, and sequelae thereof
  • Methods and compositions for treating NAFLD, hepatic steatosis, and sequelae thereof
  • Methods and compositions for treating NAFLD, hepatic steatosis, and sequelae thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0239] Example 1: Examination of Oral GLP-1 Analogs and / or Insulin Formulations for the Treatment of NAFLD

[0240] Administer one or more dosage forms and / or capsules with a pH-sensitive coating to volunteers suffering from NAFLD, which contain one or more protease inhibitors, EDTA and GLP-1 analogues on the basis of the foregoing, administer For example a time between 1-24 months. In other experiments, the dosage form contained insulin and a GLP-1 analogue. In still other experiments, subjects at risk of developing NAFLD were treated with the composition. The NAFLD status of the subjects was followed throughout the experiment to check the effectiveness of the composition.

Embodiment 2

[0241] Example 2: Examination of Oral GLP-1 Analogs and / or Insulin Formulations for Other Metabolic Indications

[0242]Volunteers with metabolic disorders (Grundy et al., 2004) administer one or more dosage forms and / or capsules with a pH-sensitive coating containing one or more protease inhibitors, EDTA and GLP-1 analogues, and administered for a period of, eg, 1-24 months. In other experiments, the dosage form contained insulin and a GLP-1 analogue. In still other experiments, subjects at risk of developing a metabolic disorder were treated with the composition. Obesity (e.g. by measuring waist circumference), total cholesterol levels, hypertriglyceridemia, serum ApoB levels, total cholesterol / HDL ratio, ApoB / ApoAl ratio, atherosclerosis, subclinical Inflammation (as measurable, inter alia, by measuring C-reactive protein levels), the presence of a prothrombotic state (such as, inter alia, measurable by measuring plasminogen activator inhibitor-1 [PAI-1] levels), the pres...

Embodiment 3

[0243] Example 3: Testing Oral GLP-1 Analog Formulations for Treatment and Prevention of Alzheimer's Disease in Animal Models

[0244] On the basis of the foregoing, one or more dosage forms containing one or more protease inhibitors, EDTA and GLP-1 analogs are administered to experimental animals under the background of the Alzheimer's disease animal model, for example, for 1-24 months time between weeks. In other experiments, formulations contained insulin and GLP-1 analogues as active drugs. In some experiments, the animal model was a streptozotocin (ST) induced AD rat model. Intracerebral injection of STZ leads to hyperphosphorylation of tau protein and creates an AD-like condition. Some experiments utilized sham-injected animals in which CSF was used instead of STZ as a control group.

[0245] After full recovery from the procedure (typically several months after induction), animals are grouped and treated with oral GLP-1 or empty vehicle (eg, saline) for several days,...

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PUM

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Abstract

Provided herein are oral pharmaceutical compositions containing a GLP-1 analogue and / or insulin for treating and reducing the incidence of nonalcoholic fatty liver disease (NAFLD), hepatic steatosis, and sequelae thereof, and methods of utilizing same.

Description

technical field [0001] Provided herein are oral pharmaceutical compositions containing GLP-1 analogues and / or insulin for the treatment and reduction of the incidence of non-alcoholic fatty liver disease (NAFLD), hepatic steatosis and its sequelae. Background technique [0002] The incretin hormone glucagon-like peptide 1 (GLP-1), secreted within minutes of food intake, is associated with the induction of insulin release. GLP-1 is used in the therapy of type 2 diabetes (T2DM). [0003] The clinical use of native GLP-1 is limited due to its rapid enzymatic inactivation resulting in a half-life of 2-3 minutes. To overcome this obstacle, natural and synthetic long-acting degradation-resistant peptides, known as GLP-1 mimetics or analogs, have been designed and are being used. [0004] Nonalcoholic fatty disease (NAFLD) is a series of chronic diseases, including hepatic steatosis or mild steatosis (bland steatosis) and sequelae of mild steatosis, such as nonalcoholic steatohep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/26A61K38/28A61K38/55A61P3/00A61K31/198
CPCA61K9/4858A61K9/4875A61K38/26A61K38/56A61K38/57A61K38/28A61K47/48215A61K9/4891A61K47/60A61K38/55A61P1/16A61P3/00A61P43/00A61K2300/00
Inventor 米丽娅姆·基德隆埃胡德·阿比特
Owner ORAMED
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