FcRn Assay for Selecting IBD Patients with His131 Allele

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Solution Overview

Problem

Current therapies for inflammatory bowel disease (IBD) are not universally effective and often come with adverse side effects, necessitating the development of assays and systems to select patients likely to respond to specific therapies and administer targeted treatments.

Innovation Solution

An assay is developed to determine the FcγR2a allele in patients, specifically identifying the His131 allele, which is associated with increased responsiveness to anti-FcRn therapy by blocking the neonatal Fc receptor (FcRn), thereby selecting patients for anti-FcRn therapy and potentially reducing IBD severity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing therapies are used to treat IBD, then some patients may experience symptom relief, but the therapies are not universally effective and cause adverse side effects

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidadverse side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent performs preliminary genetic testing for the FcγR2a His131 allele before initiating anti-FcRn therapy. This preliminary action identifies patients who are likely to respond to the treatment, allowing clinicians to select the most appropriate therapy in advance and avoid adverse effects from ineffective treatments.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies a personalized treatment approach where the therapy selection is tailored to the specific genetic characteristics of each patient. Patients with the FcγR2a His131 allele receive anti-FcRn therapy, while those without this allele receive alternative treatments, optimizing effectiveness for each individual.

Inventive Principle:
Principle #3Local quality

2Productivity

If anti-FcRn therapy is administered to all IBD patients, then some may benefit from reduced IgG levels, but non-responders waste treatment resources and experience unnecessary side effects

Engineering Contradiction:
Improvetreatment efficiencyVSAvoidtreatment resources
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent implements preliminary genetic screening for the FcγR2a His131 allele to identify patients who will respond to anti-FcRn therapy. This preliminary identification prevents waste of treatment resources on non-responders and avoids exposing them to unnecessary side effects.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies anti-FcRn therapy selectively only to the subset of patients who possess the FcγR2a His131 allele and are therefore likely to respond. This partial application of the therapy to the appropriate population maximizes treatment efficiency and resource utilization.

Inventive Principle:
Principle #16Partial or excessive action

3Measurement precision

If genetic testing for FcγR2a allele is performed, then patient selection for anti-FcRn therapy is improved, but the complexity of the treatment process increases

Engineering Contradiction:
Improvepatient selection accuracyVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex manual genetic analysis methods with automated genotyping technologies. This substitution maintains high measurement precision for FcγR2a allele identification while reducing operational complexity and making the testing process more accessible in clinical settings.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3134733B1Assay and method for treating subjects with immune-mediated diseases
Publication Date: 2020.10.14 THE BRIGHAM & WOMEN S HOSPITAL INC
  • EP3134733B1 patent drawingFigure 1
  • EP3134733B1 patent drawingFigure 2
  • EP3134733B1 patent drawingFigure 3A~3B

AI summary

Described herein are methods, assays and systems for selecting subjects with immune-mediated diseases who would optimally respond to anti-FcRn therapies and administering effective amounts of compositions comprising anti-FcRn agents for treating, inhibiting and/or reducing the symptoms of immune-mediated diseases in subjects.