IP Library Patent Application 16333171
Patent Application
App. No. 16/333,171

TREATMENT OF MULTIPLE SCLEROSIS WITH CHS-131

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Quick Facts
Patent No.
US None
App. No.
16/333,171
Abstract

Methods of treatment of multiple sclerosis (MS) in humans, and in women in particular, comprising administering CHS-131 of the following formula: (I) or a pharmaceutically acceptable salt, prodrug or isomer of CHS-131.

Claims (55)

1 . A method of treating multiple sclerosis in a woman comprising administering to a woman at regular dosing intervals a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof.

2 . The method of claim 1 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

3 . The method of claim 1 , wherein the compound of formula (I) is in the form of a besylate salt.

4 . The method of claim 1 , wherein the regular dosing interval is once daily.

5 . The method of claim 1 , wherein the therapeutically effective amount is from about 5 to about 10 milligrams.

6 . The method of claim 5 , wherein the therapeutically effective amount is about 5 milligrams.

7 . The method of claim 1 , wherein the pharmaceutical composition is administered to the woman daily and the therapeutically effective amount of the compound is about 5 milligrams.

8 . The method of claim 1 , wherein the method provides a reduction in number of new gadolinium CE T1-weighted lesions in the woman over six months by at least about 45%, at least about 50%, at least about 60%, at least about 65%, at least about 70%, or at least about 80%.

9 . A method of reducing cortical atrophy in a subject suffering from multiple sclerosis comprising administering to the subject, at regular dosing intervals, a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof.

10 . The method of claim 9 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

11 . The method of claim 9 , wherein the compound of formula (I) is in the form of a besylate salt.

12 . The method of claim 9 , wherein the regular dosing interval is once daily.

13 . The method of claim 9 , wherein the therapeutically effective amount is from about 3 to about 10 milligrams.

14 . The method of claim 13 , wherein the therapeutically effective amount is about 3 milligrams.

15 . The method of claim 9 , wherein the pharmaceutical composition is administered to the subject daily and the therapeutically effective amount of the compound is about 3 milligrams.

16 . The method of claim 9 , wherein the method reduces MS-related dysfunction.

17 . The method of claim 16 , wherein the MS-related dysfunction is determined by Expanded Disability Status Scale (EDSS) or Multiple Sclerosis Functional Composite (MSFC).

18 . A method of reducing loss of cortical volume in a subject suffering from multiple sclerosis comprising administering to the subject, at regular dosing intervals, a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof.

19 . The method of claim 18 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

20 . The method of claim 18 , wherein the compound of formula (I) is in the form of a besylate salt.

21 . The method of claim 18 , wherein the regular dosing interval is once daily.

22 . The method of claim 18 , wherein the therapeutically effective amount is from about 3 to about 10 milligrams.

23 . The method of claim 22 , wherein the therapeutically effective amount is about 3 milligrams.

24 . The method of claim 18 , wherein the pharmaceutical composition is administered to the subject daily and the therapeutically effective amount of the compound is about 3 milligrams.

25 . The method of claim 18 , wherein the method reduces MS-related dysfunction.

26 . The method of claim 25 , wherein the MS-related dysfunction is determined by Expanded Disability Status Scale (EDSS) or Multiple Sclerosis Functional Composite (MSFC).

27 . A method of treating multiple sclerosis in a subject comprising administering to the subject, at regular dosing intervals, a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof, wherein patient's loss of cortical volume is reduced and the patient's MS-related dysfunction is reduced.

28 . The method of claim 27 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

29 . The method of claim 27 , wherein the compound of formula (I) is in the form of a besylate salt.

30 . The method of claim 27 , wherein the regular dosing interval is once daily.

31 . The method of claim 27 , wherein the therapeutically effective amount is from about 3 to about 10 milligrams.

32 . The method of claim 31 , wherein the therapeutically effective amount is about 3 milligrams.

33 . The method of claim 27 , wherein the pharmaceutical composition is administered to the subject daily and the therapeutically effective amount of the compound is about 3 milligrams.

34 . The method of claim 27 , wherein the MS-related dysfunction is determined by Expanded Disability Status Scale (EDSS) or Multiple Sclerosis Functional Composite (MSFC).

35 . A method of treating multiple sclerosis in a subject comprising administering to the subject, at regular dosing intervals, a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof, wherein patient's loss of cortical volume is reduced and the number of CE lesions in the patient is reduced.

36 . The method of claim 35 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

37 . The method of claim 35 , wherein the compound of formula (I) is in the form of a besylate salt.

38 . The method of claim 35 , wherein the regular dosing interval is once daily.

39 . The method of claim 35 , wherein the therapeutically effective amount is from about 3 to about 10 milligrams.

40 . The method of claim 39 , wherein the therapeutically effective amount is about 3 milligrams.

41 . The method of claim 35 , wherein the pharmaceutical composition is administered to the subject daily and the therapeutically effective amount of the compound is about 3 milligrams.

42 . A method of treating multiple sclerosis in a subject comprising administering to the subject, at regular dosing intervals, a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I),

or a pharmaceutically acceptable salt, prodrug, or isomer thereof, wherein the subject has fewer CE lesions or T2 lesions than a subject not administered a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I).

43 . The method of claim 42 , wherein the multiple sclerosis is relapsing remitting multiple sclerosis.

44 . The method of claim 42 , wherein the compound of formula (I) is in the form of a besylate salt.

45 . The method of claim 42 , wherein the regular dosing interval is once daily.

46 . The method of claim 42 , wherein the therapeutically effective amount is from about 3 to about 10 milligrams.

47 . The method of claim 46 , wherein the therapeutically effective amount is about 3 milligrams.

48 . The method of claim 42 , wherein the pharmaceutical composition is administered to the subject daily and the therapeutically effective amount of the compound is about 3 milligrams.

49 . The method of claim 42 , wherein the subject administered a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I) has fewer CE lesions and T2 lesions than a subject not administered a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I).

Assignments (2)
TERMINATION AND RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY AT REEL/FRAME NO. 59436/0055 Recorded May 9, 2024
From: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
To: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
Reel/Frame 067378/0256 →
SECURITY INTEREST Recorded Mar 18, 2022
From: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 059436/0055 →