IP Library Granted Patent US 10,781,450
Granted Patent B2
US 10,781,450 · App. 16/357,918 · Granted Sep 22, 2020

Antisense molecules and methods for treating pathologies

Inventors: Stephen Donald Wilton (Applecross, AU); Sue Fletcher (Bayswater, AU); Abbie Adams (Kalamunda, AU); Penny Meloni (Mount Hawthorn, AU)
Assignee: Sarepta Therapeutics, Inc.
C12N15/113C12N15/111C12N2310/11C12N2310/315C12N2310/3181C12N2310/321C12N2310/3233C12N2310/351C12N2320/33
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Quick Facts
Patent No.
US 10,781,450
App. No.
16/357,918
Granted
Sep 22, 2020
Kind
B2
Abstract

An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 59.

Claims (12)

1. A method for restoring an mRNA reading frame to induce dystrophin protein production in a patient with Duchenne muscular dystrophy (DMD) in need thereof who has a mutation of the DMD gene that is amenable to exon 45 skipping, comprising administering to the patient an antisense oligonucleotide of 22 bases in length, wherein the antisense oligonucleotide is 100% complementary to a target region of exon 45 of the human dystrophin pre-mRNA, wherein the target region is annealing site H45A(−03+19), wherein the antisense oligonucleotide is a morpholino antisense oligonucleotide, and wherein the antisense oligonucleotide specifically hybridizes to the annealing site inducing exon 45 skipping, or a pharmaceutically acceptable salt thereof, thereby restoring the mRNA reading frame to induce dystrophin protein production in the patient.

2. The method of claim 1 , wherein the antisense oligonucleotide or pharmaceutically acceptable salt thereof is chemically linked to one or more moieties or conjugates that enhance the activity, cellular distribution or cellular uptake of the oligonucleotide.

3. The method of claim 1 , wherein the antisense oligonucleotide or pharmaceutically acceptable salt thereof is chemically linked to a polyethylene glycol chain.

4. A method for restoring an mRNA reading frame to induce dystrophin protein production in a patient with Duchenne muscular dystrophy (DMD) in need thereof who has a mutation of the DMD gene that is amenable to exon 45 skipping, comprising administering to the patient an antisense oligonucleotide of 22 bases in length, wherein the antisense oligonucleotide is 100% complementary to a target region of exon 45 of the human dystrophin pre-mRNA, wherein the target region is annealing site H45A(−03+19), wherein the antisense oligonucleotide is a morpholino antisense oligonucleotide, and wherein the antisense oligonucleotide specifically hybridizes to the annealing site inducing exon 45 skipping, thereby restoring the mRNA reading frame to induce dystrophin protein production in the patient.

5. The method of claim 4 , wherein the antisense oligonucleotide is chemically linked to one or more moieties or conjugates that enhance the activity, cellular distribution or cellular uptake of the oligonucleotide.

6. The method of claim 4 , wherein the antisense oligonucleotide is chemically linked to a polyethylene glycol chain.

7. A method for restoring an mRNA reading frame to induce dystrophin protein production in a patient with Duchenne muscular dystrophy (DMD) in need thereof who has a mutation of the DMD gene that is amenable to exon 45 skipping, comprising administering to the patient a pharmaceutical composition comprising (i) an antisense oligonucleotide of 22 bases in length, wherein the antisense oligonucleotide is 100% complementary to a target region of exon 45 of the human dystrophin pre-mRNA, wherein the target region is annealing site H45A(−03+19), wherein the antisense oligonucleotide is a morpholino antisense oligonucleotide, and wherein the antisense oligonucleotide specifically hybridizes to the annealing site inducing exon 45 skipping, or a pharmaceutically acceptable salt thereof, and (ii) a pharmaceutically acceptable carrier, thereby restoring the mRNA reading frame to induce dystrophin protein production in the patient.

8. The method of claim 7 , wherein the antisense oligonucleotide or pharmaceutically acceptable salt thereof is chemically linked to one or more moieties or conjugates that enhance the activity, cellular distribution or cellular uptake of the oligonucleotide.

9. The method of claim 7 , wherein the antisense oligonucleotide or pharmaceutically acceptable salt thereof is chemically linked to a polyethylene glycol chain.

10. A method for restoring an mRNA reading frame to induce dystrophin protein production in a patient with Duchenne muscular dystrophy (DMD) in need thereof who has a mutation of the DMD gene that is amenable to exon 45 skipping, comprising administering to the patient a pharmaceutical composition comprising (i) an antisense oligonucleotide of 22 bases in length, wherein the antisense oligonucleotide is 100% complementary to a target region of exon 45 of the human dystrophin pre-mRNA, wherein the target region is annealing site H45A(−03+19), wherein the antisense oligonucleotide is a morpholino antisense oligonucleotide, and wherein the antisense oligonucleotide specifically hybridizes to the annealing site inducing exon 45 skipping, and (ii) a pharmaceutically acceptable carrier, thereby restoring the mRNA reading frame to induce dystrophin protein production in the patient.

11. The method of claim 10 , wherein the antisense oligonucleotide is chemically linked to one or more moieties or conjugates that enhance the activity, cellular distribution or cellular uptake of the oligonucleotide.

12. The method of claim 10 , wherein the antisense oligonucleotide is chemically linked to a polyethylene glycol chain.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 1, 2019
From: WILTON, STEPHEN DONALD; FLETCHER, SUE; ADAMS, ABBIE; MELONI, PENNY
To: THE UNIVERSITY OF WESTERN AUSTRALIA
Reel/Frame 050587/0596 →
Priority Claims (1)
AU 2009905549 · Nov 12, 2009 · national
Continuity (5)
Division 15661750 · Jul 27, 2017
Continuation 14944886 · Nov 18, 2015
Continuation 14108137 · Dec 16, 2013
Continuation 13509331
Related Publication 20190270994A1 · Sep 5, 2019
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