Interleukin-2 for use in treating autism spectrum disorder

Patent metadata

Field	Value
Publication number	US-2026092095-A1
Application number	US-202219110627-A
Country	US
Kind code	A1
Filing date	Sep 12, 2022
Priority date	Sep 12, 2022
Publication date	Apr 2, 2026
Grant date	—

Abstract

The invention relates to the use of IL-2 in treating autism spectrum disorder (ASD) in a subject, as well as in preventing ASD in children, by administering the IL-2 to a child at risk of ASD or to a pregnant mother at risk of having a child with ASD.

First claim

1 . Interleukin-2 (IL-2) for use in treating autism spectrum disorder (ASD) in a subject.

2 . The IL-2 for use according to claim 1 , wherein the subject is a child who has been diagnosed with ASD, preferably wherein the child is between 1 and 8 years old.

3 . Interleukin-2 (IL-2) for use in preventing autism spectrum disorder (ASD) in a subject, wherein the IL-2 is administered to the subject who is an infant or a child, preferably wherein the infant or child is at risk of ASD.

4 . Interleukin-2 (IL-2) for use in preventing autism spectrum disorder (ASD) in an infant or a child, wherein the IL-2 is administered to a pregnant mother.

5 . The IL-2 for use according to claim 4 , wherein the pregnant mother is at risk of having a child with ASD, optionally wherein the pregnant mother is with ASD herself, or is or has been affected with an infection during pregnancy, or is affected with an autoimmune disease or inflammatory disorder and/or optionally wherein the pregnant mother already had a child who developed ASD, or with anti-fetal brain antibodies.

6 . The IL-2 for use according to claim 4 or 5 , wherein the IL-2 is administered during the first trimester of pregnancy.

7 . The IL-2 for use according to any of claims 1 to 6 , wherein the IL-2 is administered at a maximum dose of 3.5 MIU/day or less, preferably 3 MIU/day or less, still preferably 2 MIU/day or less, still preferably at a dose of between 0.1 and 1.5 or 2 MUI/day.

8 . The IL-2 for use according to any of claims 1-3 , wherein the IL-2 is administered to a child at a dose of between 0.1 and 1 MUI/day, or between 0.5 and 1 MIU/day.

9 . The IL-2 for use according to any of claims 1 to 8 , wherein the IL-2 is administered repeatedly, preferably in a first course that preferably consists of at least one daily administration during 1 to 7 days, followed by a maintenance course after at least 5 days, which maintenance course preferably comprises or consists of at least one administration once every week during 1 week to 3 months.

10 . The IL-2 for use according to any of claims 1 to 9 , wherein said IL-2 is human IL-2 or aldesleukin or an active analogue thereof, wherein said active analogue has at least 85% or 90% amino acid identity with human wild-type IL-2, and is capable of activating Tregs, still preferably wherein said analogue is preferably an IL2 mutein that comprises a substitution at position N88 of SEQ ID NO: 2, still preferably substitution N88R or N88D.

11 . The IL-2 for use according to any of claims 1 to 10 , wherein said IL-2 is conjugated to a PEG moiety, an Fc fragment, or any other moiety that improves the half-life of IL-2 or its diffusion in the central nervous system.

12 . The IL-2 for use according to claim 11 , wherein said IL-2 is conjugated to a beta chain of the C4b-binding protein (C4BP ) or at least one fragment or functional variant thereof that is capable of forming a dimeric protein, preferably wherein the fragment of C4BP comprises, or consists of, amino acid residues 194 to 252 of C4BP or a longer fragment of C4BP that extends at the N-term up to at most amino acid 135.

13 . The IL-2 for use according to any of claims 1 to 12 , wherein said IL-2 is expressed in vivo after administration with a nucleic acid encoding said IL-2.

14 . The IL-2 for use according to claim 13 , wherein the nucleic acid is carried by an RNA or a viral vector, preferably an adeno-virus associated virus (AAV).

15 . The IL-2 for use according to any of claims 1 to 14 , wherein said IL-2 is administered by subcutaneous, intramuscular or intradermal route.

Assignees

• Inserm Institut National De La Sante Et La Rech Medicale
• Univ Sorbonne
• Hopitaux Paris Assist Publique

Inventors

• Klaatzman David
• Ellul Pierre
• Rosenzwajg Michelle
• Delorme Richard
• Fourcade Gwladys

Classifications

• 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

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• C07K14/55 Primary

  IL-2 · CPC title

• A61K38/2013 Primary

  IL-2 · CPC title