Crystallized oxalate decarboxylase and methods of use

• US 9,714,456 B2
• Filed: 01/17/2014
• Issued: 07/25/2017
• Est. Priority Date: 01/18/2013
• Status: Active Grant

• Current Assignee: Glyscend, Inc.
• Original Assignee: Allena Pharmaceuticals, Inc.
• Inventors: Greene, Jack, Krushinskie, Dennis, Shenoy, Bhami, Johnson, Richard
• Primary Examiner(s): NOAKES, SUZANNE MARIE
• Application Number:
  US14/761,521
• Publication Number:
  US 20150353913A1
• Time in Patent Office: 1,285 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 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 1.12 to about 1.34, and the capsule comprises at least 3,000 units of oxalate decarboxylase.

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 selected from the group consisting of trehalose, sucrose, and glucose.

5. The pharmaceutical composition of claim 4, wherein the sugar is trehalose.

6. The pharmaceutical composition of claim 1, wherein the capsule is a size 1 capsule.

7. A method of reducing oxalate in a mammal, the method comprising administering the pharmaceutical composition of claim 1 to the mammal in an amount sufficient to reduce the level of oxalate in the mammal.

8. The method of claim 7, wherein the mammal suffers from a disorder selected from the group consisting of 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.