Low dose IL-2 for treating autoimmune-related or inflammatory disorders

Patent metadata

Field	Value
Publication number	US-12491232-B2
Application number	US-202318151383-A
Country	US
Kind code	B2
Filing date	Jan 6, 2023
Priority date	Mar 11, 2011
Publication date	Dec 9, 2025
Grant date	Dec 9, 2025

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.

First claim

The invention claimed is:

1 . A method for stimulating regulatory T lymphocytes (Treg) in a human patient, the method comprising administering an interleukin-2 (IL-2) to a human patient in need thereof at a dose of between 0.1 and 3.5 MIU/day in a first course of treatment, wherein the first course of treatment increases Treg cells in the subject; and wherein the first course of treatment is followed by a maintenance dose of the IL-2.

2 . The method of claim 1 , wherein the dose of IL-2 in the first course of treatment is between 1.5 to 3 MIU/day.

3 . The method of claim 2 , wherein the dose of IL-2 in the first course of treatment is 2 MIU/day.

4 . The method of claim 1 , wherein the first course of treatment comprises administration of the IL-2 once per day, for at least three consecutive days.

5 . The method of claim 1 , wherein the first course of treatment is followed by the maintenance dose of the IL-2, and wherein the maintenance dose is given to the human patient once every week to every four weeks.

6 . The method of claim 1 , wherein the first course of treatment comprises administration of the IL-2 to the human patient for 3 to 7 days.

7 . The method of claim 6 , wherein the first course of treatment comprises administration of IL-2 to the human patient for 4 to 5 days.

8 . The method of claim 1 , wherein the first course of treatment is reproduced at multiple time periods.

9 . The method of claim 8 , wherein every two consecutive time periods in the multiple time periods are interrupted by a period with no treatment.

10 . The method of claim 5 , wherein the maintenance dose starts 1 to 4 weeks after the last dose of the first course of treatment.

11 . The method of claim 5 , wherein the maintenance dose is the same as the dose in the first course of treatment.

12 . The method of claim 1 , wherein the first course of treatment increases the ratio of Tregs to effector T (Teff) cells by at least 20%.

13 . The method of claim 1 , further comprising measuring stimulation of Treg cells in the human patient.

14 . The method of claim 13 , wherein the measuring step is performed by measuring an increase in Treg counts or an increase in Treg activation markers in the human patient.

15 . The method of claim 13 , wherein the measuring step is performed by measuring the ratio between Treg cells and Teff cells in the human patient.

16 . The method of claim 1 , wherein the human patient has a neurodegenerative disease.

17 . The method of claim 1 , wherein the IL-2 is a human IL-2.

18 . The method of claim 1 , wherein the IL-2 is aldesleukin.

Assignees

• Inst Nat Sante Rech Med
• Assist Publique—Hopitaux De Paris
• Univ Sorbonne
• Hopitaux Paris Assist Publique

Inventors

• Klatzmann David
• Saadoun David
• Cacoub Patrice
• Rosenzwajg Michèle
• Piaggio Eliane
• Bensimon Gilbert
• Bernard Claude

Classifications

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K38/12

  Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)} · CPC title

• A61K38/00

  Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) · CPC title