SKAP2 Modulator Patient Stratification for IBD

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Solution Overview

Problem

Current therapeutic options for inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis, are limited, particularly for patients with moderate to severe forms who do not respond to anti-TNF therapy, and there is a need for targeted treatments that address the underlying immunopathogenesis.

Innovation Solution

Modulating the activity or expression of Src Kinase Associated Phosphoprotein 2 (SKAP2) using specific modulators, identified through genetic analysis of single nucleotide polymorphisms (SNPs), to treat IBD patients, particularly those with moderate to severe Crohn's disease, ulcerative colitis, or ulcerative colitis, by determining the presence of specific SNPs associated with subclinical phenotypes and administering a modulator to reduce SKAP2 activity or expression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anti-TNF therapy is administered to IBD patients, then inflammation is reduced, but nearly half of patients do not respond or experience loss of response over time

Engineering Contradiction:
Improvetreatment responseVSAvoidtreatment efficacy across patient populations
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent segments the IBD patient population into distinct subgroups based on SKAP2 genotype (presence or absence of specific SNPs). This segmentation allows for tailored therapeutic approaches where SKAP2-modulating agents are prescribed to patients with the specific genotype, thereby improving treatment response reliability for the targeted subgroup rather than applying a universal anti-TNF approach to all patients.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by matching specific therapeutic agents (SKAP2 modulators) to specific patient subpopulations defined by their genetic characteristics. Instead of a uniform treatment approach, the therapy is localized to patients with the appropriate SKAP2 genotype, optimizing efficacy for that specific group while acknowledging heterogeneity in the overall patient population.

Inventive Principle:
Principle #3Local quality

2Measurement precision

If targeted therapy based on SKAP2 genotype is implemented, then treatment precision is improved, but diagnostic complexity increases due to SNP analysis requirements

Engineering Contradiction:
Improvepatient stratification accuracyVSAvoidgenotyping assay requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the critical genetic information (SKAP2 SNP status) from the complex genomic landscape and uses it as the sole or primary basis for treatment decision-making. By focusing on this specific genetic marker rather than analyzing the entire genome or multiple markers, the patent simplifies the diagnostic process while maintaining high precision in patient stratification.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the diagnostic parameter from broad phenotypic assessment or multiple genetic markers to a specific genetic parameter (SKAP2 SNP presence/absence). This parameter change simplifies the diagnostic approach while improving precision in identifying patients who will respond to SKAP2-modulating therapies.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20210395827A1Methods, systems, and kits for treating inflammatory disease targeting SKAP2
Publication Date: 2021.12.23 CEDARS SINAI MEDICAL CENT
  • US20210395827A1 patent drawing
  • US20210395827A1 patent drawing
  • US20210395827A1 patent drawing

AI summary

Described herein are methods, systems, compositions, and kits useful for the diagnosis and/or treatment of a disease or condition in a subject. The present disclosure relates to methods and systems for identifying and stratifying patients suitable for treatment with a SKAP2 modulator, as described herein.