IP Library Granted Patent US 11,357,750
Granted Patent B2
US 11,357,750 · App. 16/480,773 · Granted Jun 14, 2022

Cysteamine prodrugs

Inventor: Stephen Perrett (Lawrenceville, NJ)
Assignee: Children's Hospital Medical Center
A61K31/25A61K31/573C07C323/60
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Quick Facts
Patent No.
US 11,357,750
App. No.
16/480,773
Granted
Jun 14, 2022
Kind
B2
Abstract

Described herein are prodrugs of cysteamine and pharmaceutically acceptable salts, solvates, and esters thereof. Also described herein are pharmaceutical compositions comprising prodrugs of cysteamine, or pharmaceutically acceptable salts, solvates, and esters thereof, and methods of treatment comprising administering prodrugs of cysteamine, or pharmaceutically acceptable salts, solvates, and esters thereof.

Claims (60)

1. A compound according to formula (I),

X(—R) n    (I)

or a pharmaceutically acceptable salt, solvate, or ester thereof,

wherein:

X is a pharmaceutically acceptable moiety;

R comprises a moiety which releases cysteamine after administration to a subject;

X(R) n is: (a) derived from a carbohydrate, a sugar alcohol, or polymeric alcohol, wherein at least one —OH group of the carbohydrate, the sugar alcohol, or the polymeric alcohol is replaced by R; or (b) derived from glycerol, wherein at least one —OH group of glycerol is replaced by R; and

n is a number from 1 to 100.

2. The compound of claim 1 , wherein X(R) n is derived from a carbohydrate, a sugar alcohol, or polymeric alcohol, wherein at least one —OH group of the carbohydrate, the sugar alcohol, or the polymeric alcohol is replaced by R.

3. The compound of claim 1 , wherein X(R) n is derived from polymeric alcohol, wherein at least one —OH group of the polymeric alcohol is replaced by R.

4. The compound of claim 1 , wherein X(R) n is derived from glycerol, wherein at least one —OH group of glycerol is replaced by R.

5. The compound of claim 2 , wherein the carbohydrate is selected from the group consisting of a monosaccharide, a disaccharide, an oligosaccharide, a polysaccharide, cellulose, a modified cellulosic, and starch.

6. The compound of claim 1 , wherein R comprises cysteamine, or a substituted form thereof, which is linked to X through a linking group which can be cleaved in vivo, thereby releasing cysteamine, or the substituted form thereof.

7. The compound of claim 6 , wherein the substituted form of cysteamine has the following structure:

wherein R 1 is

and

each R 2 is independently H or an alkyl.

8. The compound of claim 6 , wherein the substituted form of cysteamine has the following structure:

wherein R 1 is

and

each R 2 is independently H or an alkyl.

9. The compound of claim 6 , wherein the linking group forms a thiocarbonate or thioester which is hydrolyzed enzymatically in vivo, thereby releasing cysteamine, or the substituted form thereof.

10. The compound of claim 1 , having a structure according to formula (IIA), (IIB), or (IIE)

or a pharmaceutically acceptable salt, solvate, or ester thereof,

wherein:

each R 1 is independently H or

and

each R 2 is independently H or an alkyl.

11. The compound of claim 1 , having a structure according to formula (IIA)

or a pharmaceutically acceptable salt, solvate, or ester thereof,

wherein:

each R 1 is independently H or

and

each R 2 is independently H or an alkyl.

12. The compound of claim 6 , wherein the linking group forms a sulfoxide which is reduced and cleaved enzymatically in vivo, thereby releasing cysteamine or the substituted form thereof.

13. The compound of claim 12 , having a structure according to formula (IIC)

or a pharmaceutically acceptable salt, solvate, or ester thereof,

wherein:

each R 1 is independently H or

 and

each R 2 is independently H or an alkyl.

14. The compound of claim 6 , wherein the linking group forms a disulfide bond which is reduced in vivo, thereby releasing cysteamine.

15. The compound of claim 14 , having a structure according to formula (IID)

or a pharmaceutically acceptable salt, solvate, or ester thereof,

wherein:

each R 1 is independently H or

 and

each R 2 is independently H or an alkyl.

16. The compound of claim 1 , having a structure according to formula (III)

wherein:

each R 4 is independently H,

and at least one R is

each R 1 is independently H or

and each R 2 is independently H or alkyl.

17. The compound of claim 16 , wherein each R 4 is

each R 1 is independently H or

and each R 2 is independently H or alkyl.

18. The compound of claim 11 , having the following structure:

19. A pharmaceutical composition comprising a compound of claim 1 .

20. The pharmaceutical composition according to claim 19 , further comprising a corticosteroid.

Assignments (6)
SECURITY INTEREST Recorded Nov 8, 2022
From: ADARE PHARMACEUTICALS, INC.; ADARE PHARMACEUTICALS USA, INC.
To: TEAL MIDCO HOLDINGS, L.P.
Reel/Frame 061698/0541 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2021
From: ELLODI PHARMACEUTICALS, LP
To: CHILDREN'S HOSPITAL MEDICAL CENTER
Reel/Frame 056631/0555 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2021
From: ADARE PHARMACEUTICALS, INC.
To: ADARE PHARMACEUTICALS US, L.P.
Reel/Frame 056139/0788 →
CHANGE OF NAME Recorded May 5, 2021
From: ADARE PHARMACEUTICALS US, L.P.
To: ELLODI PHARMACEUTICALS, L.P.
Reel/Frame 056140/0048 →
SECURITY INTEREST Recorded Sep 22, 2020
From: ADARE PHARMACEUTICALS, INC.; ADARE PHARMACEUTICALS USA, INC.
To: CRESCENT AGENCY SERVICES LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 053849/0967 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2019
From: PERRETT, STEPHEN
To: ADARE PHARMACEUTICALS, INC.
Reel/Frame 049860/0713 →