Systemic allergic response risk assessment in peanut oral immunotherapy

An immunotherapy and allergic reaction technology, applied in allergic diseases, biological testing, biological material analysis, etc., can solve problems such as difficult to explain the undeclared ingredients of food labels

Pending Publication Date: 2022-01-04
SOC DES PROD NESTLE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, accidental ingestion of peanuts is common due to difficulty interpreting food labels and the presence of undeclared ingredients in unlabeled foods

Method used

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  • Systemic allergic response risk assessment in peanut oral immunotherapy
  • Systemic allergic response risk assessment in peanut oral immunotherapy
  • Systemic allergic response risk assessment in peanut oral immunotherapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Example 1: European Phase 3 Clinical Trial Measuring Oral Immunotherapy Success of AR101 in Peanut Allergic Children test

[0096] The following study is a European multicenter randomized double-blind placebo-controlled clinical trial entitled "European AR101 Trial Measuring the Success of Oral Immunotherapy in Children with Peanut Allergy (ARTEMIS)", investigating the effect of a peanut protein preparation (AR101) on peanut allergy Efficacy and safety in an individual's characterized desensitized oral immunotherapy regimen. Pediatric and adolescent patients aged 4-17 years are considered eligible. All participants had a clinical history of peanut allergy (confirmed by screening a double-blind placebo-controlled food challenge (DBPCFC)) and a serum peanut-specific IgE (psIgE) ≥0.35 kU A / L (via UniCAP TM (Phadia AB, Uppsala, Sweden) confirmed within the past 12 months) and / or peanut skin prick test mean wheal diameter ≥3mm larger than negative control (eg, saline)...

Embodiment 2

[0119] The clinical safety test of embodiment 2.AR101

[0120] In addition to the studies discussed in Example 1, the efficacy and safety of a peanut protein formulation (AR101 ) in a characterized desensitization oral immunotherapy regimen for peanut-allergic individuals was investigated in the following four clinical trials. Two studies, called ARC003 and ARC007, were completed, and their open-label extension studies, called ARC004 and ARC011, are ongoing. For ongoing studies, the data presented are from the cut-off date of 15 December 2018.

[0121] ARC003 (also known as PALISADE) was a large double-blind placebo-controlled Phase 3 study of AR101 in peanut allergy patients aged 4 to 55 years and was the first to include a double-blind placebo at both entry and exit Controlled food challenge (DBPCFC) test. See Jones et al., "Efficacy and Safety of AR101 in PeanutAllergy: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (PALISADE)," J. Allergy Cl...

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Abstract

Described herein are methods of assessing risk of a systemic allergic response in a subject being treated for a peanut allergy by an oral immunotherapy. The oral immunotherapy includes administering to the subject a composition comprising peanut protein according to an oral immunotherapy schedule comprising an up-dosing phase and a maintenance phase. The methods can include obtaining a peanut-specific IgE level when the subject tolerates the dose of 1000 mg or more peanut protein; and assessing the risk of a systemic allergenic response in the subject based on the obtained peanut- specific IgE level.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application No. 62 / 822,705, filed March 22, 2019, and U.S. Provisional Application No. 62 / 897,086, filed September 6, 2019, each entitled "SYSTEMICALLERGIC RESPONSE RISK ASSESSMENT IN PEANUT ORAL IMMUNOTHERAPY" Priority benefit, each of these two patents is hereby incorporated by reference for all purposes. technical field [0003] This article describes an approach for the treatment of peanut allergy using oral immunotherapy that includes a dosing phase and a maintenance phase. Background technique [0004] Peanut allergy is an allergic, hypersensitivity reaction of the immune system to peanut protein. Peanut allergy usually develops in childhood and is often a lifelong affliction. Allergic reactions to peanuts can be serious and life-threatening, and are a major source of severe food-induced anaphylaxis. [0005] Until recently, the standard of care for the management of pe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/68
CPCG01N33/686G01N2800/24A61P37/08A61K9/0053A61K39/35G01N33/6854
Inventor S·G·迪利
Owner SOC DES PROD NESTLE SA
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