IL-5 Binding Protein Dosing Regimen for Asthma Treatment

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Solution Overview

Problem

There is a need for more effective treatments for asthma, particularly for IL-5 mediated diseases that have a reduced dosing profile.

Innovation Solution

A pharmaceutical composition comprising an antigen binding protein that binds to IL-5, administered in a novel dose and dosage regimen of 100 mg to 300 mg every 6 months, specifically designed for treating IL-5 mediated diseases such as asthma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing IL-5 targeting monoclonal antibodies are used for treating IL-5 mediated diseases, then disease symptoms can be controlled, but the dosing frequency is high (every 4-8 weeks) which reduces patient compliance

Engineering Contradiction:

Improvedisease control efficacyVSAvoidpatient compliance

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by modifying the dosing interval from every 4-8 weeks to every 6 months, and adjusting the dose amount to 100-300 mg. This fundamental parameter change in the dosage regimen enables extended dosing intervals while maintaining therapeutic efficacy, directly resolving the contradiction between disease control reliability and patient compliance.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If existing IL-5 targeting monoclonal antibodies are used for treating IL-5 mediated diseases, then asthma exacerbations can be reduced, but the treatment requires frequent administration which increases treatment burden

Engineering Contradiction:

Improvereduction of asthma exacerbationsVSAvoidtreatment time commitment

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent changes the dosing parameters from frequent administration (every 4-8 weeks) to extended interval dosing (every 6 months) at 100-300 mg. This parameter transformation maintains the reliability of reducing asthma exacerbations while dramatically reducing the time commitment required for treatment, as patients only need to visit the clinic once every 6 months instead of monthly or quarterly.

Inventive Principle:

Principle #35Parameter changes

3Duration of action of stationary object

If higher doses of IL-5 binding proteins are administered, then treatment duration can be extended, but the safety profile may be compromised

Engineering Contradiction:

Improvedosing intervalVSAvoidsafety profile

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent optimizes the dose parameters to 100-300 mg administered every 6 months, finding the optimal balance between extending dosing interval and maintaining safety. This parameter optimization ensures therapeutic efficacy is maintained while minimizing potential safety concerns associated with higher doses, resolving the contradiction between extended duration of action and safety profile.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20250042985A1Interleukin 5 binding protein dosage regimen for use in treating polyangiitis, hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps (crswnp), or chronic rhinosinusitis without nasal polyps (crssnp)

Publication Date: 2025.02.06 GLAXOSMITHKLINE INTPROP DEV LTD

AI summary

The present disclosure relates to pharmaceutical compositions comprising from about 100 mg to about 300 mg of an antigen binding protein which binds to IL-5. Compositions and antigen binding proteins of the disclosure are useful in the treatment of IL-5 mediated diseases, such as EGPA, HES, CRSsNP and CRSwNP, and can be administered about once every 6 months.