# US 2024/0189395 A1 · Compositions, systems, and methods for treating or reducing hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in neonates

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- Number: US 2024/0189395 A1
- Document ID: US20240189395A1
- Status: Published application
- Kind: A1
- Application number: 18/584,727
- Filed: 2024-02-22
- Published: 2024-06-13
- Earliest claimed: 2019-06-03
- Assignees: University of Mississippi Medical Center
- Applicants: University of Mississippi Medical Center
- Inventors: Lir-Wan Fan; Abhay Jyotindrabhai Bhatt
- Web page: https://patentgrep.com/patent/US20240189395A1

## CPC

- A61K 38/28: Insulins
- A61K 9/0043: {Nose}
- A61P 25/00: Drugs for disorders of the nervous system
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method for treating or reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in neonates utilizes a relative high dose of nasally administered insulin. In one aspect, the method includes intranasally administering, to a neonate in need thereof, an effective dose of insulin comprising between 350 U to 2000 U insulin.

## Claims

### Claim 1

A method for treating or reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in preterm neonates, comprising intranasally administering, to a preterm neonate in need thereof, an effective dose of insulin comprising between 350 U to 2000 U insulin.

### Claim 2 (depends on 1)

The method of claim 1, wherein the effective dose of insulin is calculated at between 75 U to 700 U insulin per kilogram of the neonate.

### Claim 3 (depends on 2)

The method of claim 2, wherein intranasally administering the effective dose of insulin comprises intranasally delivering half of the effective dose to each nare of the neonate.

### Claim 4 (depends on 2)

The method of claim 2, wherein the effective dose comprises 1200-1400 U insulin, the effective dose being delivered intranasally at 600 U to 700 U insulin to each nare of the neonate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the neonate is less than 36 weeks of gestational age at birth.

### Claim 6 (depends on 1)

The method of claim 1, wherein the method further comprises identifying the neonate as having experienced, or who is suspected as having experienced, a hypoxic-ischemic event.

### Claim 7 (depends on 6)

The method of claim 6, wherein the experienced or suspected hypoxic-ischemic event occurs at delivery or post-delivery.

### Claim 8 (depends on 1)

The method of claim 1, wherein the intranasal administration is provided to the neonate at one or more days between delivery and 28 days post-delivery of the neonate.

### Claim 9 (depends on 6)

The method of claim 6, wherein the intranasal administration is provided to the neonate only one time, the intranasal administration being provided within 1 hour to 1 day after the neonate experiences or is suspected of the hypoxic-ischemic event.

### Claim 10 (depends on 8)

The method of claim 8, wherein the intranasal administration is provided to the neonate in the form of a nasal spray.

### Claim 11 (depends on 8)

The method of claim 8, wherein intranasal administration comprises administering 25 μL to 150 μL of the nasal spray to each nare of the neonate.

### Claim 12 (depends on 8)

The method of claim 8, wherein intranasal administration comprises administering 50 μL of the nasal spray to each nare of the neonate at a concentration between 10,000 U/mL and 15,000 U/mL.

### Claim 13 (depends on 1)

The method of claim 1, wherein the intranasal administration is provided to the neonate without causing systemic hypoglycemia.

### Claim 14

A method for treating or reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in preterm neonates, comprising:
identifying a preterm neonate having experienced, or who is suspected as having experienced, a hypoxic-ischemic event;
intranasally administering between 175 U and 1000 U insulin to each nare of the neonate without causing systemic hypoglycemia; and
reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in the neonate.

### Claim 15 (depends on 14)

The method of claim 14, wherein the neonate is less than 36 weeks of gestational age at birth.

### Claim 16 (depends on 14)

The method of claim 14, wherein intranasal administration comprises administering 50 μL of a nasal spray to each nare of the neonate at a concentration of 14.000 U/mL.