FABAC-Thyroid Agonist Combination for Liver Disease

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Solution Overview

Problem

Current treatments for liver diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and fibrosis are ineffective and often associated with toxicity and side effects, highlighting an unmet medical need for safe and effective therapeutic interventions.

Innovation Solution

A therapeutic combination of fatty acid-bile acid conjugates (FABACs) and thyroid hormone receptor agonists or mimetics, administered together to treat, stabilize, or reduce the severity or progression of liver diseases, including NAFLD, NASH, and fibrosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments for liver diseases are used, then some therapeutic effect may be achieved, but toxicity and side effects occur

Engineering Contradiction:
Improvetherapeutic effectVSAvoidtoxicity and side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines two distinct therapeutic agents with different mechanisms of action: fatty acid-bile acid conjugates (which reduce hepatic steatosis through bile acid signaling) and thyroid hormone receptor agonists (which increase metabolic rate and lipid oxidation). This combination creates a synergistic effect that improves therapeutic efficacy while allowing lower doses of each individual agent, thereby reducing toxicity and side effects compared to monotherapy at higher doses.

Inventive Principle:
Principle #5Merging (Combining)

2Duration of action of moving object

If available treatments for fatty liver disease are used, then some symptom relief may be achieved, but long term treatment is limited by toxicity and side effects

Engineering Contradiction:
Improvetreatment durationVSAvoidtoxicity and side effects
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the dosing parameters by using lower doses of each individual agent in combination, rather than high doses of a single agent. This parameter change allows for long-term treatment sustainability because the reduced individual doses minimize cumulative toxicity and side effects, enabling patients to maintain therapy over extended periods without treatment discontinuation due to adverse effects.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If monotherapy with single agents is used, then treatment simplicity is maintained, but therapeutic efficacy is insufficient

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges two orally administrable agents into a single combination therapy regimen. Both the fatty acid-bile acid conjugate and thyroid hormone receptor agonist can be administered together in a single daily dose, maintaining treatment simplicity from the patient's perspective while achieving superior therapeutic efficacy through the complementary mechanisms of action of the two agents.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12239712B2Combination therapy for the treatment of liver disease
Publication Date: 2025.03.04 GALMED RESEARCH & DEVELOPMENT LTD
  • US12239712B2 patent drawing
  • US12239712B2 patent drawing
  • US12239712B2 patent drawing

AI summary

The invention relates to pharmaceutical compositions, and more specifically to pharmaceutical compositions comprising at least one fatty acid-bile acid conjugate and at least one thyroid hormone receptor agonist or thyroid hormone mimetic or pharmaceutically acceptable salts thereof, and use of such compositions in methods of treating, stabilizing or lessening the severity or progression of a liver disease including fibrosis, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and comorbidity ties associated with a liver disease.