Testosterone-SAG Combination for Remyelination in Demyelinating Disease

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Solution Overview

Problem

Current treatments for demyelinating diseases, such as multiple sclerosis, are ineffective in progressive forms and often associated with significant side effects, and there is a need for methods that promote remyelination effectively.

Innovation Solution

Administering a steroid hormone, specifically testosterone, in combination with a Hedgehog signaling pathway modulator, such as the Smoothened agonist SAG, to synergistically enhance the production of oligodendrocytes and myelin-producing cells, promoting remyelination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments (immunomodulators) are used to treat progressive forms of multiple sclerosis, then some effectiveness is achieved, but major side effects occur and tolerance is poor

Engineering Contradiction:
Improveeffectiveness in progressive formsVSAvoidside effects and tolerance
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the therapeutic approach by shifting from immunomodulation to remyelination promotion through Hedgehog pathway activation and steroid hormone administration, fundamentally altering the mechanism of action to achieve effectiveness in progressive forms without the harmful side effects of current immunomodulators

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the harmful effect of demyelination into a beneficial process by activating endogenous remyelination mechanisms through Hedgehog pathway modulation, transforming the disease state into a regenerative opportunity

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

2Ease of operation

If current treatments are used to improve function after attacks, then symptom management is achieved, but new attacks continue to occur

Engineering Contradiction:
Improvefunction improvementVSAvoidprevention of new attacks
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by promoting remyelination before new demyelinating attacks occur, creating a protective myelin layer that prevents future attacks and improves functional outcomes before disease progression can manifest

Inventive Principle:
Principle #10Preliminary action

3Reliability

If immunomodulators are used to prevent new attacks, then attack prevention is achieved, but the treatments are expensive and have significant side effects

Engineering Contradiction:
Improveprevention of new attacksVSAvoidcost and side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent enables self-service by activating the body's own remyelination capabilities through Hedgehog pathway modulation and steroid hormone administration, eliminating the need for expensive immunomodulators and their associated side effects while maintaining attack prevention

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The combination therapy significantly increases the number of oligodendrocytes and myelin-producing cells, leading to improved remyelination and more effective treatment of demyelinating diseases, including multiple sclerosis.

Implementation Method 1

The Hedgehog signaling pathway modulator is the Smoothened (Smo) agonist 3-Chloro-N-[trans-4-(methylamino)cyclohexyl]-N-[[3-(4-pyridinyl)phenyl]methyl]benzo[b]thiophene-2-carboxamide (SAG)

Methodology Applied
Scientific EffectHedgehog signaling pathway activation:

Implementation Method 2

The steroid hormone is the androgen receptor ligand testosterone

Methodology Applied
Scientific EffectSteroid hormone receptor binding:

Data Source

PatentEP3737471B1Combination comprising testosterone and the hedgehog signaling pathway modulator SAG for use in the treatment of demyelinating diseases
Publication Date: 2026.02.18 M & P PHARMA
  • EP3737471B1 patent drawingFigure 1A~1D
  • EP3737471B1 patent drawingFigure 2A~2B
  • EP3737471B1 patent drawingFigure 3A~3D

AI summary

Described herein are methods of promoting remyelination in a subject suffering from demyelination diseases by administering to the subject a combination of steroid hormones and Hedgehog signaling pathway modulators. Also described are methods of administering the combination of drugs, wherein the combination of drugs are in compositions adapted for nasal administration.