IP Library Granted Patent US 12,297,431
Granted Patent B2
US 12,297,431 · App. 17/813,249 · Granted May 13, 2025

Modulation of huntingtin expression

Inventors: Gene Hung (Carlsbad, CA); C. Frank Bennet (Carlsbad, CA); Susan M. Freier (San Diego, CA); Holly Kordasiewicz (San Diego, CA); Lisa Stanek (Cambridge, MA); Don W. Cleveland (Del Mar, CA); Seng H. Cheng (Natick, MA); Lamya Shihabuddin (Brighton, MA)
Assignee: Ionis Pharmaceuticals, Inc.
C12N15/113C12N2310/11C12N2310/113C12N2310/315C12N2310/321C12N2310/3341C12N2310/341C12N2310/345C12N2310/346
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Quick Facts
Patent No.
US 12,297,431
App. No.
17/813,249
Granted
May 13, 2025
Kind
B2
Abstract

Provided herein are methods, compounds, and compositions for reducing expression of huntingtin mRNA and protein in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate Huntington's disease, or a symptom thereof.

Claims (18)

1. A compound comprising a single-stranded modified oligonucleotide, wherein the single-stranded modified oligonucleotide is a gapmer consisting of a 5′ wing segment, a central gap segment, and a 3′ wing segment, wherein:

the 5′ wing segment consists of five linked nucleosides,

the central gap segment consists of ten linked deoxynucleosides, and the 3′ wing segment consists of five linked nucleosides,

wherein each nucleoside of each wing segment comprises a 2′-O-methoxyethyl sugar, wherein the single-stranded modified oligonucleotide has the nucleobase sequence of 5′-CTCAGTAACATTGACACCAC-3′ (SEQ ID NO: 22), wherein each cytosine is a 5-methylcytosine, and wherein each internucleoside linkage of the single-stranded modified oligonucleotide is either a phosphorothioate internucleoside linkage or a phosphodiester internucleoside linkage; and

wherein each internucleoside linkage within the gap segment is a phosphorothioate linkage, the internucleoside linkage connecting the central gap segment to the 5′ wing segment is a phosphorothioate linkage, the internucleoside linkage connecting the central gap segment to the 3′ wing segment is a phosphorothioate linkage, the 5′-most internucleoside linkage of the 5′ wing segment is a phosphorothioate linkage, and the 3′-most internucleoside linkage of the 3′ wing segment is a phosphorothioate linkage; and the remaining internucleoside linkages are phosphodiester linkages.

2. The compound of claim 1 , consisting of the single-stranded modified oligonucleotide.

3. The compound of claim 1 , consisting of the single-stranded modified oligonucleotide covalently linked to a conjugate group.

4. The compound of claim 1 , wherein the compound is a pharmaceutically acceptable salt.

5. The compound of claim 4 , wherein the pharmaceutically acceptable salt is a sodium salt or a potassium salt.

6. A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier or diluent.

7. The pharmaceutical composition of claim 6 , wherein the compound consists of the single-stranded modified oligonucleotide.

8. The pharmaceutical composition of claim 6 , wherein the compound consists of the single-stranded modified oligonucleotide covalently linked to a conjugate group.

9. The pharmaceutical composition of claim 6 , wherein the compound is a pharmaceutically acceptable salt.

10. A pharmaceutical composition consisting essentially of the compound of claim 1 and PBS.

11. A method for reducing huntingtin mRNA levels in an animal, the method comprising administering to the animal a therapeutically effective amount of the pharmaceutical composition of claim 6 .

12. The method of claim 11 , wherein the single-stranded modified oligonucleotide covalently linked to a conjugate group.

13. The method of claim 11 , wherein the compound is a pharmaceutically acceptable salt.

14. The method of claim 13 , wherein the pharmaceutically acceptable salt is a sodium salt or a potassium salt.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2022
From: CHENG, SENG H.; SHIHABUDDIN, LAMYA; STANEK, LISA
To: GENZYME CORPORATION
Reel/Frame 061113/0269 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2022
From: HUNG, GENE; BENNETT, C. FRANK; FREIER, SUSAN M.; KORDASIEWICZ, HOLLY; CLEVELAND, DON W.
To: ISIS PHARMACEUTICALS
Reel/Frame 060551/0052 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2022
From: CHENG, SENG H.; SHIHABUDDIN, LAMYA; STANEK, LISA
To: GENZYME CORPORATION
Reel/Frame 060551/0075 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2022
From: GENZYME CORPORATION
To: ISIS PHARMACEUTICALS, INC.
Reel/Frame 060551/0115 →
CHANGE OF NAME Recorded Jul 19, 2022
From: ISIS PHARMACEUTICALS, INC.
To: IONIS PHARMACEUTICALS, INC.
Reel/Frame 060750/0865 →