IP Library Granted Patent US 11,286,485
Granted Patent B2
US 11,286,485 · App. 16/840,249 · Granted Mar 29, 2022

Oligonucleotides for modulating ATXN2 expression

Inventors: Peter Hagedorn (Horsholm, DK); Dennis Jul Hansen (Farum, DK); Heidi Rye Hudlebusch (Brønshøj, DK); Lykke Pedersen (Copenhagen NV, DK); Søren Vestergaard Rasmussen (Espergærde, DK); Mette Ladefoged (Birkerød, DK)
Assignee: HOFFMANN-LA ROCHE INC.
C12N15/113A61K31/7125A61P25/28
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Quick Facts
Patent No.
US 11,286,485
App. No.
16/840,249
Granted
Mar 29, 2022
Kind
B2
Abstract

The present invention relates to antisense oligonucleotides that are capable of modulating expression of ATXN2 in a target cell. The oligonucleotides hybridize to ATXN2 mRNA. The present invention further relates to conjugates of the oligonucleotide and pharmaceutical compositions and methods for treatment of neurodegenerative diseases such as spinocerebellar ataxia type 2 (SCA2), amyotrophic lateral sclerosis (ALS), Alzheimer's frontotemporal dementia (FTD), parkinsonism and conditions with TDP-43 proteinopathies using the oligonucleotide.

Claims (15)

1. An antisense oligonucleotide of formula TCAcAttttactttaacCTC (SEQ ID NO 15_4) wherein capital letters are beta-D-oxy LNA nucleosides, lowercase letters are DNA nucleosides, all LNA C are 5-methyl cytosine, all internucleoside linkages are phosphorothioate internucleoside linkages.

2. The antisense oligonucleotide of claim 1 , wherein the antisense oligonucleotide is of formula

or a pharmaceutically acceptable salt thereof.

3. The antisense oligonucleotide according to claim 1 or claim 2 , wherein the antisense oligonucleotide is in the form of a pharmaceutically acceptable salt.

4. The antisense oligonucleotide according to claim 1 or claim 2 , wherein the antisense oligonucleotide is in the form of a pharmaceutically acceptable sodium salt.

5. The antisense oligonucleotide according to claim 1 or claim 2 , wherein the antisense oligonucleotide is in the form of a pharmaceutically acceptable potassium salt.

6. A conjugate comprising the antisense oligonucleotide according to claim 1 , and at least one conjugate moiety covalently attached to said oligonucleotide.

7. A pharmaceutical composition comprising the antisense oligonucleotide of claim 1 and a pharmaceutically acceptable diluent, solvent, carrier, salt and/or adjuvant.

8. The pharmaceutical composition according to claim 7 , wherein the composition comprises a pharmaceutically acceptable diluent.

9. The pharmaceutical composition according to claim 8 , wherein the pharmaceutically acceptable diluent is sterile phosphate buffered saline.

10. The pharmaceutical composition according to claim 7 wherein the antisense oligonucleotide is used in the pharmaceutically acceptable diluent at a concentration of 1-100 mg/mL solution.

11. The pharmaceutical composition according to claim 10 , wherein the antisense oligonucleotide is used in the pharmaceutically acceptable diluent at a concentration of 2-30 mg/mL.

12. An in vivo or in vitro method for modulating ATXN2 expression in a target cell which is expressing ATXN2, said method comprising administering an antisense oligonucleotide of claim 1 or claim 2 in an effective amount to said cell.

13. A method for treating a patient for a neurodegenerative disease selected from the group consisting of spinocerebellar ataxia type 2 (SCA2), amyotrophic lateral sclerosis (ALS), Alzheimer's, frontotemporal dementia (FTD), parkinsonism and conditions with TDP-43 proteinopathies, comprising administering a therapeutically effective amount of the antisense oligonucleotide of claim 1 or claim 2 to the patient.

14. The method of claim 13 , wherein the neurodegenerative disease is spinocerebellar ataxia type 2 (SCA2).

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2020
From: HUDLEBUSCH, HEIDI; PEDERSEN, LYKKE; RASMUSSEN, SOREN VESTERGAARD
To: ROCHE INNOVATION CENTER COPENHAGEN A/S
Reel/Frame 052467/0238 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2020
From: HAGEDORN, PETER; HUDLEBUSCH, HEIDI RYE; PEDERSEN, LYKKE; RASMUSSEN, SOREN VESTERGAARD
To: ROCHE INNOVATION CENTER COPENHAGEN A/S
Reel/Frame 052467/0422 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2020
From: HAGEDORN, PETER; HANSEN, DENNIS JUL; HUDLEBUSCH, HEIDI RYE; PEDERSEN, LYKKE; LADEFOGED, METTE
To: ROCHE INNOVATION CENTER COPENHAGEN A/S
Reel/Frame 052455/0833 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2020
From: ROCHE INNOVATION CENTER COPENHAGEN A/S
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 052455/0960 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2020
From: F. HOFFMANN-LA ROCHE AG
To: HOFFMANN-LA ROCHE INC.
Reel/Frame 052456/0229 →
Priority Claims (3)
EP 19167386 · Apr 4, 2019 · regional
EP 19167388 · Apr 4, 2019 · regional
EP 19167394 · Apr 4, 2019 · regional
Continuity (5)
Continuation In Part 16545823 · Aug 20, 2019
Continuation In Part PCTEP2019064276 · Jun 3, 2019
Continuation In Part 16430339 · Jun 3, 2019
Continuation In Part PCTEP2019064274 · Jun 3, 2019
Related Publication 20210024925A1 · Jan 28, 2021