Crystallized oxalate decarboxylase and methods of use

• US 10,570,468 B2
• Filed: 02/14/2019
• Issued: 02/25/2020
• 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:
  US16/275,734
• Publication Number:
  US 20200024673A1
• Time in Patent Office: 376 Days
• Field of Search: None
• 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 method of reducing oxalate concentration in the plasma of a subject, the method comprising administering to the subject at least one capsule comprising crystals of spray-dried oxalate decarboxylase comprising the amino acid sequence of SEQ ID NO:

1, wherein the thiol moiety at Cys383 is protected by a thiol protecting group, and wherein the crystals have a Hausner ratio of about 1.00 to about 1.59, thereby to reduce oxalate concentration in the plasma of the subject.

2. The method of claim 1, wherein the capsule further comprises an excipient.

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

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

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

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

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

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

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

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

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

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

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

14. The method of claim 1, wherein the capsule comprises at least 5,000 U of oxalate decarboxylase crystals.

15. The method of claim 1, wherein the capsule comprises at least 3,000 U of oxalate decarboxylase crystals.