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GLP-2 analogs and peptibodies for administration before during, or after surgery

A GLP-2, post-operative technology, applied in the direction of peptides, hormone peptides, specific peptides, etc., can solve the problems that have not been studied and the potential of additional benefits of GLP-2 receptor agonists is not obvious

Pending Publication Date: 2020-09-04
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The potential for additional benefit of pharmacological doses of GLP-2 receptor agonists in these patients is not evident and has not been studied

Method used

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  • GLP-2 analogs and peptibodies for administration before during, or after surgery
  • GLP-2 analogs and peptibodies for administration before during, or after surgery
  • GLP-2 analogs and peptibodies for administration before during, or after surgery

Examples

Experimental program
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Effect test

example 1

[0188] Example 1: Histological study of villus length and ductal depth in GLP-2 peptibody B264

[0189] Various doses of GLP-2 peptibody B264 were analyzed to assess the pharmacodynamic platform, primary endpoints were measurements of small intestine weight relative to total body weight and histological studies of villus length. Eleven groups of six female CD-1 mice each were formed. The groups are summarized in Table 1 below.

[0190] Table 1

[0191] Group

[0192] For histology, four micron paraffin sections were prepared for H&E and Ki67 IHC staining. After whole slide scanning, villi length and ductal depth were measured using a videograph, and Ki67 was analyzed. Antibodies against Ki67 are Rabbit antibody sold, catalog number ab 616667. Antibodies were used at a working concentration of 1:100 and Refine kit to detect. Ki67 staining results are shown in Figure 4 , 5A and 5B. The GLP-2 peptibody B264, GLP-2 peptibody K274, and GLP-2[A2G] peptides l...

example 2

[0193] Example 2: Administration of GLP-2 peptibodies to patients prior to surgery

[0194] Within a month, a patient with Crohn's disease was scheduled for small bowel resection surgery. It is expected that the patient will have a small bowel of 150 cm length after surgery. The small intestine is expected to remain continuous with the colon. The patient is expected to develop mild short bowel syndrome and will require parenteral nutritional support. At a dose of approximately 1.4 mg / kg, patients will be given weekly GLP-2 peptibodies were administered subcutaneously. Patients will be monitored for any side effects regarding digestion and intestinal absorption.

example 3

[0195] Example 3: Administration of teduglutide to a patient prior to surgery

[0196] Within a month, a patient with Crohn's disease was scheduled for small bowel resection surgery. It is expected that the patient will have a small bowel of 150 cm length after surgery. The small intestine is expected to remain continuous with the colon. The patient is expected to develop mild short bowel syndrome and will require parenteral nutritional support. Patients will be administered 0.05 mg / kgh(Gly2) intravenously daily as part of a treatment plan to reduce postoperative inflammation (a problem associated with Crohn's disease) and minimize the need for parenteral nutritional support GLP-2. Patients will be monitored for any side effects regarding digestion and intestinal absorption.

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Abstract

GLP-2 analogs, such as teduglutide, and fusion proteins of GLP-2 with immunoglobulin are administered before, during or after surgery, particularly resection of the small intestine. When short bowel syndrome develops after surgical resection of the small intestine, parenteral nutrition is usually necessary to compensate for reduced absorption of water and nutrients across the small intestine. GLP-2 analogs and GLP-2 fusion proteins promote growth of small intestine, improve nutrient absorption and can reduce the need for parenteral nutrition after surgery.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 582,055, filed November 6, 2017, the disclosure of which is incorporated herein by reference in its entirety. Background technique [0003] The estimated incidence of short bowel syndrome (SBS) patients with non-malignant disease requiring home parenteral nutrition (HPN) is at least 40 cases per million US population. SBS usually results from the surgical removal of some or most of the small bowel due to conditions such as Crohn's disease, mesenteric infarction, volvulus, trauma, congenital anomalies, and multiple lesions due to adhesions or radiation Narrow sex. Surgical resection can also involve removing all or part of the colon. SBS patients suffer from malabsorption which can cause malnutrition, dehydration and weight loss. Some patients may overeat to maintain their protein and energy balance; more rarely, they may maintain fluid and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/17
CPCA61K38/26A61P1/14A61P3/00C07K2319/00A61P1/00C07K16/00A61K47/6811C07K14/605
Inventor C·潘A·诺顿B·施特拉克-洛格C·奥利维尔
Owner TAKEDA PHARMA CO LTD
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