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Treatment of celiac disease with tolerizing particles

A technology for celiac disease and granules, which is applied in the direction of antibody medical ingredients, medical preparations with non-active ingredients, and medical preparations containing active ingredients.

Pending Publication Date: 2020-10-30
КОР ФАРМАСЬЮТИКАЛЗ ДИВЕЛОПМЕНТ КОМПАНИ ИНК
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these treatments produced only marginal efficacy in clinical trials (Kaukinen 2014)

Method used

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  • Treatment of celiac disease with tolerizing particles
  • Treatment of celiac disease with tolerizing particles
  • Treatment of celiac disease with tolerizing particles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-TI

[0077] Example 1 - TIMP-GLIA first administration regimen in humans

[0078] Previous toxicology studies in animals showed TIMP-GLIA doses of 0, 10, 50, 75, 100 and 200 mg / kg (HED: 0, 1.6, 8, 12, 16 and 32 mg / kg), and administered intravenously on days 1 and 8, and autopsy was performed on days 15 or 17, depending on tissue / blood sampling requirements. In conclusion, TIMP-GLIA at 10 mg / kg produced no significant toxicological or pathological effects when administered intravenously on days 1 and 8. At doses >50 mg / kg, a number of clinicopathological and microhistopathological effects were observed mainly in the liver and spleen. At 200 mg / kg, two animals were euthanized due to drug related effects.

[0079] The TIMP-GLIA purified by the above product was intravenously administered to rats (10 / sex / Group). Infusions occurred on days 1, 8, and 15, and autopsies were performed on day 16. An additional 5 rats / sex / group received the same dosing regimen with a 28-day recovery p...

Embodiment 2

[0125] Safety and tolerability assessment of TIMP-GLIA administered for the first time in humans

[0126] In this study, the criteria for conducting the study listed in Example 1 above were used with the modifications described below.

[0127] For inclusion criteria, patients were adult males or females aged 18 to 75 years (inclusive) at the screening visit. Subjects had a body mass index (BMI) >16kg / m at the screening visit 2 , with a minimum weight of 33 kg and a maximum weight of 129 kg (inclusive), and if BMI 25 (“overweight” or “obese”), otherwise in the investigator's opinion yes healthy.

[0128] Genotyping is not required for patients with CD, but biopsy-proven CD is sufficient. Also, subjects had no known gluten exposure for at least 10 days prior to the screening visit and maintained a gluten-free diet for the duration of the study.

[0129] Study: To establish the safety, tolerability and pharmacokinetics (PK) of TIMP-GLIA in humans, 23 subjects with biopsy-prov...

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Abstract

The present disclosure relates to methods for treating Celiac Disease using tolerizing immune modifying particles that encapsulate antigenic material from the gliadin protein or other related proteins.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 628,233, filed February 8, 2018, which is hereby incorporated by reference in its entirety. technical field [0003] The present disclosure relates to methods of treating celiac disease using tolerance immune-modifying particles that encapsulate antigenic material from gliadin or other related proteins. [0004] Incorporation by reference of material submitted electronically [0005] This application contains the Sequence Listing in computer readable form (filename: 52341_Seqlisting.txt; 6,713 bytes; created February 8, 2019) as a separate part of the disclosure, which is incorporated by reference in its entirety. Background technique [0006] Celiac disease (CD) is a common immune disorder with an estimated prevalence of 0.3% to 2.4% in people of European ancestry (Fasano 2012). The disease develops in genetically susceptib...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/16A61K9/127A61K39/35A61K39/385
CPCA61K39/35A61K39/385A61K2039/55555A61K9/0019A61K9/19A61K47/34A61P37/02A61K2039/6093A61K47/6937A61K38/011A61K45/06
Inventor D·R·盖茨
Owner КОР ФАРМАСЬЮТИКАЛЗ ДИВЕЛОПМЕНТ КОМПАНИ ИНК