# US 10,765,709 B2 · Compositions and methods for the treatment or prevention of oxalate-related disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,709 B2 - Document ID: US10765709B2 - Status: Granted - Kind: B2 - Application number: 16/308,439 - Filed: 2017-06-13 - Published: 2019-05-02 - Granted: 2020-09-08 - Earliest claimed: 2016-06-13 - Assignees: Oxthera Intellectual Property AB - Applicants: Oxthera Intellectual Property AB - Inventors: Elisabeth Lindner; Maria Åkerman; Anna Sjögren; Orla McCallion - Web page: https://patentgrep.com/patent/US10765709B2 ## CPC - A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00) - A61K 9/4866: {Organic macromolecular compounds} - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present disclosure is related to pharmaceutical compositions and methods for treating and/or preventing oxalate-related disorders. More particularly, the present disclosure pertains to compositions comprising an oxalate-degrading bacteria Oxalobacter formigenes particularly suitable for the treatment and/or prevention of late stage hyperoxaluria characterized by high plasma-oxalate levels and a progressing decrease in kidney function. ## Claims ### Claim 1 An enteric-coated capsule for oral administration of Oxalobacter formigenes to a subject in need thereof, comprising a pharmaceutical composition comprising: (i) 10% to 25% by dry weight of Oxalobacter formigenes; (ii) 50% to 65% by dry weight of sucrose; (iii) about 10% to 30% by dry weight of one or more cryopreserving agents and/or excipients; wherein said enteric-coated capsule delivers Oxalobacter formigenes to the small intestine and/or to the ileum, and wherein the in vitro oxalate-degrading activity of the Oxalobacter formigenes present in said enteric-coated capsule is no less than (NLT) 100 mmol/capsule/19 hours. ### Claim 2 (depends on 1) The enteric-coated capsule according to claim 1, wherein said pharmaceutical composition comprises 15% to 25% by dry weight of Oxalobacter formigenes. ### Claim 3 (depends on 2) The enteric-coated capsule according to claim 2, wherein said pharmaceutical composition comprises 17% to 22% by dry weight of Oxalobacter formigenes. ### Claim 4 (depends on 1) The enteric-coated capsule according to claim 1, wherein the cryopreserving agents and/or excipients are selected from maltodextrin, oligofructose, and alginate. ### Claim 5 (depends on 4) The enteric-coated capsule according to claim 4, wherein said pharmaceutical composition comprises 15% to 21% by dry weight of maltodextrin as a cryopreserving agent. ### Claim 6 (depends on 4) The enteric-coated capsule according to claim 4, wherein said pharmaceutical composition comprises 16% to 19% by dry weight of maltodextrin as a cryopreserving agent. ### Claim 7 (depends on 4) The enteric-coated capsule according to claim 4, wherein said pharmaceutical composition comprises 1% to 5% by dry weight of oligofructose and 0.5% to 2% by dry weight of alginate as cryopreserving agents. ### Claim 8 (depends on 7) The enteric-coated capsule according to claim 7, wherein said pharmaceutical composition further comprises 1% to 5% by weight of water. ### Claim 9 (depends on 4) The enteric-coated capsule according to claim 4, wherein said pharmaceutical composition comprises 0.5% to 1.5% by dry weight of alginate as a cryopreserving agent. ### Claim 10 (depends on 1) The enteric-coated capsule according to claim 1, wherein said pharmaceutical composition comprises (i) 17% to 22% by dry weight of Oxalobacter formigenes; (ii) 52% to 62% by dry weight of sucrose; and (iii) 17% to 25% by dry weight of one or more cryopreserving agents and/or excipients. ### Claim 11 (depends on 1) The enteric-coated capsule according to claim 1, wherein said pharmaceutical composition comprises: (i) about 19% by dry weight of Oxalobacter formigenes; (ii) about 57% by dry weight of sucrose; (iii) about 21% by dry weight of one or more cryopreserving agents and/or excipients, and (iv) q.s. water. ### Claim 12 (depends on 11) The enteric-coated capsule according to claim 11, wherein said about 21% by dry weight of one or more cryopreserving agents and/or excipients comprises about 1% by dry weight of alginate, about 17% by dry weight of maltodextrin, and about 3% by dry weight of oligofructose. ### Claim 13 (depends on 1) The enteric-coated capsule according to claim 1, wherein said pharmaceutical composition comprises: (i) 19%±1-3% by dry weight of Oxalobacter formigenes; (ii) 57%±1-3% by dry weight of sucrose; and (iii) 21%±1-3% by dry weight of one or more cryopreserving agents and/or excipient comprising 1%±1% by dry weight of alginate, 17%±1-3% by dry weight of maltodextrin and by dry weight 3%±1-3% of oligofructose. ### Claim 14 (depends on 1) The enteric-coated capsule according to claim 1, wherein said enteric-coated capsule shows essentially no disintegration within one hour of incubation in Simulated Gastric Fluid (SGF) having a pH of about 1.2±0.1 and comprising about 3.2 mg/ml of pepsin at a temperature of about 37° C., and a start of disintegration of said capsule is detected within about one hour in Simulated Intestinal Fluid (SIF) having a pH of about 6.8±0.1 and comprising about 10 mg/ml of pancreatin at about 37° C. ### Claim 15 (depends on 1) The enteric-coated capsule according to claim 1, wherein said pharmaceutical composition comprises Oxalobacter formigenes in an amount of from about 109 to about 1010 CFU. ### Claim 16 (depends on 1) A method for treating or preventing an oxalate-related disorder, comprising administering a pharmaceutically effective amount of an enteric-coated capsule according to claim 1 to a subject in need thereof. ### Claim 17 (depends on 16) The method of claim 16, wherein said oxalate-related disorder is selected from a calcium-oxalate deposition related disorder involving hyperoxalemia, hyperoxaluria with hyperoxalemia, primary hyperoxaluria, secondary hyperoxaluria, hyperoxalemia, accumulation of oxalate in blood plasma, oxalosis associated with Chronic Kidney Disease (CKD) or end stage renal disease (ESRD), bariatric surgery with jejunal/ileal resection or Roux-en-Y procedures, Zellweger's disease, cancers with jejunal/ileal resection, renal infections with Aspergillus niger, ESRD-patients on dialysis, oxalate-related inflammation, cardiac conductance disorders, vulvodynia, idiopathic calcium oxalate kidney stone disease (urothiliasis), inflammatory bowel disease (IBS), Small Intestine Bacterial Overgrowth (SIBS), gastroenteritis, gastritis, enteritis, enterocolitis, ulcerative colitis, Crohn's disease, or an oxalate-related disorder in a patient treated with a gastrointestinal lipase inhibitor. ### Claim 18 (depends on 16) The method of claim 16, wherein the method is effective to increase systemic oxalate excretion in said subject. ### Claim 19 (depends on 16) The method of claim 16, wherein said pharmaceutically effective amount comprises Oxalobacter formigenes in an amount of about 109 to about 1010 CFUs. ### Claim 20 (depends on 19) The method of claim 19, wherein said method comprises administering said pharmaceutically effective amount at least twice a day for a continuous period of time of months or years, or until the levels of plasma oxalate have been lowered, and are maintained at a level of about 1-3 μmol/L.