IGF-I and IGFBP-3 Composition for Preterm Infant Complications

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Solution Overview

Problem

Current treatments for complications related to premature birth, such as low birth weight and retinopathy of prematurity, are ineffective in addressing the underlying issues of low serum levels of insulin-like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3), leading to developmental delays and severe health issues in preterm infants.

Innovation Solution

A composition comprising IGF-I or its analog in combination with IGFBP-3 or its analog, with a molar ratio lower than equimolar, is administered to preterm infants to elevate serum levels of IGF-I and IGFBP-3 to in utero norms, using routes like intravenous, subcutaneous, or oral administration, to prevent complications like developmental delay, bronchopulmonary dysplasia, and retinopathy of prematurity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If preterm infants receive standard care without IGF-I and IGFBP-3 supplementation, then the treatment is simple and成本低, but the infants suffer from low serum levels of IGF-I and IGFBP-3 leading to developmental delays and severe health issues

Engineering Contradiction:
Improvehealth outcomes of preterm infantsVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces IGF-I and IGFBP-3 as intermediary substances that mediate between the preterm infant's underdeveloped physiological systems and the desired growth and development outcomes. These growth factors act as biological mediators that facilitate tissue growth, organ maturation, and metabolic regulation, thereby improving health outcomes without requiring complex mechanical or surgical interventions.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the biochemical parameters of the preterm infant's system by supplementing IGF-I and IGFBP-3 to achieve serum levels comparable to in utero conditions. This parameter change approach restores the physiological balance of growth factors, enabling normal developmental processes that were disrupted by premature birth.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If IGF-I is administered alone to elevate serum levels, then the treatment is simpler, but the effectiveness is reduced compared to combination therapy with IGFBP-3

Engineering Contradiction:
Improveeffectiveness of treatmentVSAvoidcomposition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges IGF-I and IGFBP-3 into a single therapeutic composition, combining two biologically active substances that work synergistically. IGFBP-3 serves as a binding protein that regulates IGF-I availability, and their combination creates a more stable and effective treatment that better mimics the natural in utero environment where both substances coexist.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent employs a composite therapeutic material consisting of IGF-I and IGFBP-3 in specific proportions. This composite composition leverages the complementary functions of both substances: IGF-I provides direct growth stimulation while IGFBP-3 modulates its release and half-life, creating a sustained therapeutic effect that neither substance could achieve alone.

Inventive Principle:
Principle #40Composite materials

3Reliability

If the molar ratio of IGF-I to IGFBP-3 is set at equimolar, then the composition is simpler to formulate, but the effectiveness is reduced compared to non-equimolar ratios

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidformulation precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent optimizes the molar ratio parameter of IGF-I to IGFBP-3 to fall within 1:4 to 1:20, based on physiological data from in utero conditions. This parameter optimization ensures that the therapeutic composition replicates the natural balance of growth factors present during fetal development, maximizing therapeutic effectiveness while preventing overstimulation or imbalance.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS9463222B2Methods for treatment of complications of prematurity comprising administration of IGF-I and IGFBP-3
Publication Date: 2016.10.11 SHIRE HUMAN GENETIC THERAPIES INC
  • US9463222B2 patent drawing
  • US9463222B2 patent drawing
  • US9463222B2 patent drawing

AI summary

The present invention relates to a composition comprising Insulin Growth Factor I (IGF-I) or an analog thereof in combination with Insulin Growth Factor Binding Protein (IGFBP) or an analog thereof, said combination having a molar ratio of IGF-I to IGFBP 5 being lower than equimolar, preferably in the range from 1:20 to 1:3.33, for use in the treatment of a patient suffering from complications of preterm birth, very preterm birth and/or extremely preterm birth, as well as a method for treating a patient suffering from complications of preterm birth, very preterm birth and/or extremely preterm birth.