IL-1 Receptor-Fc Fusion Protein for Refractory Pericarditis

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Solution Overview

Problem

Current treatments for pericarditis, particularly refractory and recurrent forms, are inadequate, with existing medications posing safety risks and side effects, and there is a need for a more effective and safer therapeutic option.

Innovation Solution

Administration of a recombinant IL-1 receptor-Fc fusion protein acts as a soluble decoy receptor, blocking IL-1α/IL-1β interaction, thereby reducing inflammation and associated symptoms in pericarditis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current medications (NSAIDs, colchicine, corticosteroids) are used to treat pericarditis, then inflammation and symptoms are reduced, but safety risks and side effects increase

Engineering Contradiction:
Improvetreatment efficacyVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses an IL-1 receptor-Fc fusion protein as a soluble decoy receptor that acts as an intermediary to bind IL-1α and IL-1β, preventing these cytokines from interacting with their natural cell surface receptors. This intermediary mechanism blocks the inflammatory signaling pathway without requiring direct activation of immune cells, thereby reducing inflammation while avoiding the harmful side effects of traditional medications like NSAIDs, colchicine, and corticosteroids

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent converts the harmful inflammatory response caused by IL-1α and IL-1β into a beneficial therapeutic effect by using a fusion protein that specifically targets and neutralizes these cytokines. The IL-1 receptor-Fc fusion protein binds to the harmful cytokines with high affinity, effectively converting the pathogenic inflammatory signaling into a controlled therapeutic intervention that reduces inflammation without the systemic side effects of conventional drugs

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

2Reliability

If IL-1β inhibition alone is used, then some inflammatory outcomes are improved, but disease remission is insufficient in the absence of IL-1α inhibition

Engineering Contradiction:
Improvedisease remissionVSAvoidcoverage of inflammatory pathways
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent creates a universal therapeutic agent that addresses multiple inflammatory pathways simultaneously. The IL-1 receptor-Fc fusion protein is designed to bind both IL-1α and IL-1β with comparable affinity, providing multi-functional inhibition of the IL-1 signaling pathway. This universal approach ensures comprehensive coverage of inflammatory mechanisms, achieving disease remission in cases where single-cytokine inhibition would be insufficient

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of operation

If traditional anti-inflammatory medications are used, then pericarditis symptoms are managed, but treatment safety and tolerability deteriorate

Engineering Contradiction:
Improvesymptom managementVSAvoidtreatment safety
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs a soluble IL-1 receptor-Fc fusion protein as a mediator that specifically intercepts IL-1α and IL-1β before they can activate inflammatory signaling. This targeted intermediary approach provides effective symptom management while maintaining treatment safety, as the fusion protein selectively neutralizes pathogenic cytokines without causing the systemic side effects associated with traditional anti-inflammatory medications

Inventive Principle:
Principle #24Intermediary (Mediator)

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 IL-1 receptor-Fc fusion protein significantly reduces pericarditis-related inflammation and pain, improves cardiac pathology, and offers a favorable safety profile with minimal adverse effects.

Implementation Method 1

the recombinant IL-1-Fc fusion protein used in the present invention acts as a soluble decoy receptor binding IL-1α/IL-1β and prevents their interaction with the IL-1 cell surface receptor

Methodology Applied
Scientific EffectReceptor-ligand binding: Absorption (physical)

Data Source

PatentUS20250345396A1Treatment of inflammatory conditions by delivery of interleukin-1 receptor antagonist fusion protein
Publication Date: 2025.11.13 REGENERON PHARMACEUTICALS INC
  • US20250345396A1 patent drawing
  • US20250345396A1 patent drawing
  • US20250345396A1 patent drawing

AI summary

The present invention provides, among other things, methods of treating post-cardiac injury syndrome (PCIS) or pericarditis, comprising a step of administering to a subject in need of treatment an interleukin-1 receptor-Fc fusion protein at a therapeutically effective dose and an administration interval for a treatment period sufficient to improve, stabilize or reduce one or more signs and symptoms of pericarditis relative to a control.