Inflammatory Biomarkers Predict FGF-18 Cartilage Treatment Response

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Solution Overview

Problem

Current treatments for cartilage disorders, such as osteoarthritis, lack predictive biomarkers to determine the effectiveness of FGF-18 compound treatments, leading to variable responses among patients.

Innovation Solution

The use of inflammatory biomarkers like C1M, C3M, and CRPM to predict the sensitivity of patients with cartilage disorders to FGF-18 compound treatments, allowing for personalized dosing regimens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If FGF-18 compound treatment is administered to patients with cartilage disorders, then cartilage repair and regeneration may be achieved, but treatment response varies significantly among patients without predictive biomarkers

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpredictive biomarker information
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent applies preliminary action by measuring inflammatory biomarker levels (C1M, C3M, CRPM) before FGF-18 compound treatment to predict patient response. This pre-treatment assessment allows clinicians to identify good-responders and low-responders in advance, enabling informed treatment decisions before administering the compound.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback by using baseline inflammatory biomarker levels as predictive indicators that inform treatment planning. The biomarker measurements provide feedback about patient-specific characteristics that will influence treatment response, allowing for personalized dosing regimens and treatment strategies.

Inventive Principle:
Principle #23Feedback

2Ease of operation

If standardized FGF-18 dosing regimens are used for all patients, then treatment administration is simplified, but treatment outcomes vary due to individual patient differences

Engineering Contradiction:
Improvetreatment administrationVSAvoidtreatment outcome consistency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies local quality by tailoring FGF-18 dosing regimens to individual patient characteristics based on their inflammatory biomarker levels. Instead of a uniform approach, patients are stratified into good-responders and low-responders who receive customized treatment protocols, optimizing efficacy for each patient group.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent implements parameter changes by adjusting FGF-18 dosing parameters (dose, frequency, duration) based on patient-specific biomarker profiles. The treatment protocol modifies administrative parameters according to the predictive biomarker assessment, transitioning from standardized dosing to personalized dosing regimens.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If FGF-18 treatment is administered without biomarker prediction, then all patients receive potential benefit, but low-responders undergo unnecessary therapy with associated risks and costs

Engineering Contradiction:
Improvetreatment efficiencyVSAvoidunnecessary treatment exposure
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The patent applies taking out by extracting or identifying the subset of patients most likely to benefit from FGF-18 treatment based on their inflammatory biomarker profiles. By separating good-responders from low-responders using biomarker prediction, the treatment is targeted to those who will experience meaningful benefit, avoiding unnecessary exposure for low-responders.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS12332250B2Inflammatory biomarkers for predicting responsiveness to FGF-18 compound
Publication Date: 2025.06.17 MERCK PATENT GMBH
  • US12332250B2 patent drawing
  • US12332250B2 patent drawing
  • US12332250B2 patent drawing

AI summary

The present invention relates to biomarkers associated with the clinical response to an FGF-18 compound before or during treatment of a cartilage disorder. It relates more particularly to specific proteins present in the blood, serum, synovial fluid or in the urine, which can be used as biomarkers for the diagnosis, pre-treatment of patients and during therapy of cartilage disorders. The invention can be used in predicting the response to an FGF-18 compound treatment, before starting the treatment or during the treatment. It could be used for selecting/identifying subjects to be treated according to specific doses and/or dosing regimens by intra-articular administration of an FGF-18 compound. The use of these biomarkers in diagnostics could result in increased benefit and reduced risk-benefit ratio in subjects.