THR-β Agonist Dosing via SHBG Biomarker Testing
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Solution Overview
Problem
Current therapies are lacking for non-alcoholic steatohepatitis (NASH), a progressive liver disease that can lead to cirrhosis and liver failure, with no specific treatments available.
Innovation Solution
A method involving baseline and benchmark biomarker tests to determine dosages of a thyroid hormone receptor-β (THR-β) agonist, such as resmetirom, for administering to subjects to treat or prevent liver disorders, including NASH, with dosage adjustments based on age and biomarker responses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If no specific therapies are available for NASH, then the unmet medical need remains high, but treatment efficacy cannot be achieved
Solution Approach 1:
The patent employs biomarker-based dosage adjustment by measuring SHBG levels to personalize THR-β agonist treatment. This parameter change approach transforms the one-size-fits-all therapy model into a precision medicine approach where dosage is optimized based on individual patient biomarker profiles, thereby achieving treatment efficacy while addressing the lack of available therapies
Solution Approach 2:
The patent implements a feedback mechanism through baseline and benchmark biomarker testing to monitor treatment response. By measuring SHBG levels before and during treatment, the system provides feedback that guides dosage adjustments, ensuring effective treatment while adapting to individual patient responses to THR-β agonists
2Measurement precision
If uniform dosing is used for all patients, then ease of administration is maintained, but individual treatment response optimization is lost
Solution Approach 1:
The patent changes the dosage parameter based on measured SHBG biomarker levels. By establishing threshold values and corresponding dosage recommendations, the system achieves precise dosage optimization without requiring complex real-time adjustments, balancing measurement precision with operational simplicity
Solution Approach 2:
The patent performs baseline biomarker testing before treatment initiation to pre-determine the appropriate starting dosage. This preliminary action eliminates the need for frequent dosage adjustments during treatment, maintaining ease of administration while achieving individualized dosage optimization from the outset
Data Source
AI summary
The present disclosure provides a method of treating or preventing a liver disorder (e.g., NASH) in a subject with a THR-β agonist, using a biomarker test (e.g., to determine a dose of the THR-β agonist).