Long-acting Growth Hormone Formulation for Reduced Non-responder Rates

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Solution Overview

Problem

Current long-acting growth hormone formulations have not demonstrated superior efficacy compared to daily somatropin, and there is a need for a formulation that reduces the percentage of non-responders in growth hormone deficiency treatment.

Innovation Solution

A long-acting growth hormone formulation with a pharmacokinetic profile providing sustained exposure, administered at a dose of 0.24 mg/kg/week, which leads to superior efficacy and reduced non-responder rates compared to daily somatropin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If daily somatropin is administered, then treatment compliance is maintained, but treatment burden and patient inconvenience increase

Engineering Contradiction:

Improvetreatment complianceVSAvoidinjection frequency

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies periodic action by formulating growth hormone with a depot carrier system that releases the hormone over extended periods (weekly, biweekly, or monthly), transforming daily injections into less frequent administrations while maintaining therapeutic efficacy and patient compliance

Inventive Principle:

Principle #19Periodic action

2Ease of operation

If long-acting growth hormone formulations are developed, then injection frequency is reduced, but efficacy compared to daily somatropin has not been proven superior

Engineering Contradiction:

Improveinjection frequencyVSAvoidefficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent employs parameter changes by modifying the pharmacokinetic parameters of growth hormone through formulation with specific depot carriers and controlled release mechanisms, achieving both reduced injection frequency and proven superior efficacy through clinical trial data showing enhanced height velocity and IGF-1 levels

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent utilizes composite materials by combining growth hormone with depot carrier systems (such as polymeric or liposomal formulations) to create a long-acting composite preparation that maintains sustained release characteristics while demonstrating superior therapeutic efficacy

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If current long-acting growth hormone formulations are used, then weekly or monthly administration is possible, but the percentage of non-responders remains high

Engineering Contradiction:

Improveadministration frequencyVSAvoid responder rate

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent implements feedback mechanisms through personalized dosing strategies and monitoring of growth responses, allowing adjustment of formulation and dose based on individual patient responses to maximize efficacy and reduce non-responder rates while maintaining convenient administration intervals

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS12303553B2Long-acting growth hormone dosage forms with superior efficacy to daily somatropin

Publication Date: 2025.05.20 ASCENDIS PHARMA ENDOCRINOLOGY DIV AS

AI summary

A long-acting growth hormone or a pharmaceutical formulation comprising such long-acting growth hormone for use in a method of treating growth hormone deficiency with improved outcomes is described.