Crystallized oxalate decarboxylase and methods of use

• US 10,246,755 B2
• Filed: 06/23/2017
• Issued: 04/02/2019
• Est. Priority Date: 01/18/2013
• Status: Active Grant

• Current Assignee: Glyscend, Inc.
• Original Assignee: Allena Pharmaceuticals, Inc.
• Inventors: Greene, Jack, Johnson, Richard, Krushinskie, Dennis, Shenoy, Bhami
• Primary Examiner(s): Noakes, Suzanne M
• Application Number:
  US15/630,978
• Publication Number:
  US 20180087119A1
• Time in Patent Office: 648 Days
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/51 Lyases (4)
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: C12N 9/88 Lyases (4.)
• CPC Class Codes: C12Y 401/01002 Oxalate decarboxylase (4.1.1.2)

Abstract

Pharmaceutical compositions comprising spray-dried oxalate decarboxylase crystals are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using compositions comprising spray-dried oxalate decarboxylase crystals are also disclosed.

Claims

1. A pharmaceutical composition comprising a capsule containing crystals of spray-dried oxalate decarboxylase comprising the amino acid sequence of SEQ ID NO:

1 where the thiol moiety at Cys383 is protected by a reaction with a thiol protecting group, wherein the crystals have a Hausner ratio of about 1.00 to about 1.59.

2. The pharmaceutical composition of claim 1, further comprising an excipient.

3. The pharmaceutical composition of claim 2, wherein the excipient is a sugar.

4. The pharmaceutical composition of claim 3, wherein the sugar is a disaccharide or a monosaccharide.

5. The pharmaceutical composition of claim 4, wherein the sugar is selected from trehalose, sucrose, and glucose.

6. The pharmaceutical composition of claim 5, wherein the sugar is trehalose.

7. The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio of about 1.00 to about 1.34.

8. The pharmaceutical composition of claim 7, wherein the crystals have a Hausner ratio of about 1.00 to about 1.25.

9. The pharmaceutical composition of claim 8, wherein the crystals have a Hausner ratio of about 1.00 to about 1.18.

10. The pharmaceutical composition of claim 9, wherein the crystals have a Hausner ratio of about 1.12 to about 1.18.

11. The pharmaceutical composition of claim 8, wherein the crystals have a Hausner ratio of about 1.19 to about 1.25.

12. The pharmaceutical composition of claim 7, wherein the crystals have a Hausner ratio of about 1.26 to about 1.34.

13. The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio of about 1.34.

14. The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio less than 1.34.

15. The pharmaceutical composition of claim 1, wherein the capsule is a size 0 capsule and comprises at least 5,000 U of oxalate decarboxylase crystals.

16. The pharmaceutical composition of claim 1, wherein the capsule is a size 1 capsule and comprises at least 3,000 U of oxalate decarboxylase crystals.

17. The pharmaceutical composition of claim 16, wherein the capsule comprises at least 6,000 U of oxalate decarboxylase crystals.

18. The pharmaceutical composition of claim 16, wherein the capsule comprises between 6,000 U and 21,000 U of oxalate decarboxylase crystals.

19. A method of treating a disorder associated with elevated oxalate concentration in a mammal, the method comprising administering the pharmaceutical composition of claim 1 comprising a capsule containing crystals of spray-dried oxalate decarboxylase to the mammal in an amount sufficient to reduce one or more symptoms associated with the disorder.

20. The method of claim 19, wherein the disorder is related to a kidney or a liver function.

21. The method of claim 19, wherein the disorder is selected from primary hyperoxaluria, enteric hyperoxaluria, idiopathic hyperoxaluria, ethylene glycol poisoning, cystic fibrosis, inflammatory bowel disease, urolithiasis, nephrolithiasis, chronic kidney disease, hemodialysis, gastrointestinal bypass, and kidney stones.

22. The method of claim 19, wherein the pharmaceutical composition further comprises an excipient.

23. The method of claim 22, wherein the excipient is a sugar.

24. The method of claim 23, wherein the sugar is a disaccharide or a monosaccharide.

25. The method of claim 24, wherein the sugar is selected from trehalose, sucrose, and glucose.

26. The method of claim 25, wherein the sugar is trehalose.

27. The method of claim 19, wherein the crystals have a Hausner ratio of about 1.00 to about 1.34.

28. The method of claim 27, wherein the crystals have a Hausner ratio of about 1.00 to about 1.25.

29. The method of claim 28, wherein the crystals have a Hausner ratio of about 1.00 to about 1.18.

30. The method of claim 29, wherein the crystals have a Hausner ratio of about 1.12 to about 1.18.

31. The method of claim 28, wherein the crystals have a Hausner ratio of about 1.19 to about 1.25.

32. The method of claim 27, wherein the crystals have a Hausner ratio of about 1.26 to about 1.34.

33. The method of claim 19, wherein the crystals have a Hausner ratio of about 1.34.

34. The method of claim 19, wherein the crystals have a Hausner ratio less than 1.34.

35. The method of claim 19, wherein the capsule is a size 0 capsule and comprises at least 5,000 U of oxalate decarboxylase crystals.

36. The method of claim 19, wherein the capsule is a size 1 capsule and comprises at least 3,000 U of oxalate decarboxylase crystals.

37. The pharmaceutical composition of claim 36, wherein the capsule comprises at least 6,000 U of oxalate decarboxylase crystals.

38. The pharmaceutical composition of claim 36, wherein the capsule comprises between 6,000 U and 21,000 U of oxalate decarboxylase crystals.