# US 10,765,723 B2 · Use of low dose IL-2 for treating autoimmune—related or inflammatory disorders

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- Number: US 10,765,723 B2
- Document ID: US10765723B2
- Status: Granted
- Kind: B2
- Application number: 16/361,902
- Filed: 2019-03-22
- Published: 2019-11-21
- Granted: 2020-09-08
- Earliest claimed: 2011-03-11
- Assignees: Inserm (Institut National De La Sante Et De La Recherche Medicale); Assistance Publique-Hopitaux de Paris; Sorbonne Universite
- Applicants: INSERM (Institut National de la Santé et de la Recherche Médicale); Assistance Publique—Hopitaux De Paris; Sorbonne Universite
- Inventors: David Klatzmann; David Saadoun; Patrice Cacoub; Michèle Rosenzwajg; Eliane Piaggio; Gilbert Bensimon; Claude Bernard
- Web page: https://patentgrep.com/patent/US10765723B2

## CPC

- A61K 38/2013: {IL-2}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/14: of the thyroid hormones, e.g. T3, T4
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/06: Antiasthmatics
- A61P 15/06: Antiabortive agents; Labour repressants
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/14: for RNA viruses
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- 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

The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.

## Claims

### Claim 1

A method for treating systemic vasculitis, the method comprises administering to a human subject in need thereof an effective amount of repeated doses of interleukin-2 (IL-2), wherein each dose of the IL-2 is between 0.1 MIU/day and 3.5 MIU/day.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is administered IL-2 at a dose of 1 MIU/day to 3.5 MIU/day.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is administered IL-2 at a dose of 1.5 MIU/day to 3.5 MIU/day.

### Claim 4 (depends on 1)

The method of claim 1, wherein the subject is administered IL-2 at a dose of 0.5 MIU/day to 1.5 MIU/day.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject is administered IL-2 at a dose of 1.5 MIU/day.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject is administered des-alanyl-1, serine-125 human interleukin-2.

### Claim 7 (depends on 1)

The method of claim 1, wherein the IL-2 is administered once per day during at least 3 consecutive days.

### Claim 8 (depends on 1)

The method of claim 1, wherein the IL-2 is administered to the subject in a first course of treatment once per day during 3 to 7 days, followed by a maintenance dose given to the subject once a week, once a month, or twice a month.

### Claim 9 (depends on 8)

The method of claim 8, wherein the maintenance dose is administered one to four weeks after the last dose of the first course of treatment.

### Claim 10 (depends on 1)

The method of claim 1, wherein the IL-2 is administered by a subcutaneous route.