IP Library Granted Patent US 11,491,238
Granted Patent B2
US 11,491,238 · App. 16/938,274 · Granted Nov 8, 2022

Exon skipping oligomer conjugates for muscular dystrophy

Inventors: Richard K. Bestwick (Cambridge, MA); Frederick Joseph Schnell (Cambridge, MA)
Assignee: Sarepta Therapeutics, Inc.
A61K47/6807A61K9/0019C07K14/4707C12N15/113C12N15/62C12N2310/11C12N2310/3233
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Quick Facts
Patent No.
US 11,491,238
App. No.
16/938,274
Granted
Nov 8, 2022
Kind
B2
Abstract

Antisense oligomers complementary to a selected target site in the human dystrophin gene to induce exon 52 skipping are described.

Claims (23)

1. A method for treating Duchenne muscular dystrophy (DMD) in a subject in need thereof wherein the subject has a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

2. The method of claim 1 , wherein the antisense oligomer is of Formula (VIIA):

3. A method of restoring an mRNA reading frame to induce dystrophin production in a subject having a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

4. A method for treating Duchenne muscular dystrophy (DMD) in a subject in need thereof wherein the subject has a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject a pharmaceutical composition comprising an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

5. A method of restoring an mRNA reading frame to induce dystrophin production in a subject having a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject a pharmaceutical composition comprising an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

6. A method of excluding exon 52 from dystrophin pre-mRNA during mRNA processing in a subject having a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject a pharmaceutical composition comprising an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

7. A method of binding exon 52 of dystrophin pre-mRNA in a subject having a mutation of the dystrophin gene that is amenable to exon 52 skipping, the method comprising administering to the subject a pharmaceutical composition comprising an antisense oligomer of Formula (VIIA):

or a pharmaceutically acceptable salt thereof.

8. The method of claim 1 , wherein the antisense oligomer is administered weekly.

9. The method of claim 1 , wherein the antisense oligomer is administered biweekly.

10. The method of claim 1 , wherein the antisense oligomer is administered every third week.

11. The method of claim 1 , wherein the antisense oligomer is administered monthly.

12. The method of claim 1 , wherein the antisense oligomer is administered at a dose selected from about 30 mg/kg, about 40 mg/kg, about 60 mg/kg, about 80 mg/kg, and about 160 mg/kg.

13. The method of claim 3 , wherein the antisense oligomer is administered weekly.

14. The method of claim 3 , wherein the antisense oligomer is administered biweekly.

15. The method of claim 3 , wherein the antisense oligomer is administered every third week.

16. The method of claim 3 , wherein the antisense oligomer is administered monthly.

17. The method of claim 3 , wherein the antisense oligomer is administered at a dose selected from about 30 mg/kg, about 40 mg/kg, about 60 mg/kg, about 80 mg/kg, and about 160 mg/kg.

Assignments (2)
SECURITY INTEREST Recorded May 7, 2025
From: SAREPTA THERAPEUTICS, INC.
To: JPMORGAN CHASE BANK, N.A. AS ADMINISTRATIVE AGENT
Reel/Frame 071218/0445 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 6, 2023
From: BESTWICK, RICHARD K.; SCHNELL, FREDERICK JOSEPH
To: SAREPTA THERAPEUTICS, INC.
Reel/Frame 064173/0651 →