# US 2016/0256533 A1 · Safe and effective beta-lactamase dosing for microbiome protection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2016/0256533 A1 - Document ID: US20160256533A1 - Status: Published application - Kind: A1 - Application number: 15/062,559 - Filed: 2016-03-07 - Published: 2016-09-08 - Earliest claimed: 2015-03-06 - Assignees: Synthetic Biologics, Inc. - Applicants: Synthetic Biologics, Inc. - Inventors: Joseph Sliman - Web page: https://patentgrep.com/patent/US20160256533A1 ## CPC - A61K 38/50: acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase - A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 9/5078: {with drug-free core} - A61K 31/546: containing further heterocyclic rings, e.g. cephalothin - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system - C12Y 305/02006: Beta-lactamase (3.5.2.6) - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - 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 - C12Y: ENZYMES - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract The present invention relates to, inter alia, safe and effective doses of a beta-lactamase for, e.g. microbiome protection. ## Claims ### Claim 1 A method of protecting a patient's gastrointestinal microbiome, comprising administering an effective amount of a pharmaceutical composition comprising a beta-lactamase to a patient in need thereof, wherein: the patient is undergoing treatment or has recently undergone treatment with a beta-lactam antibiotic, optionally selected from a penicillin and a cephalosporin; the beta-lactamase comprises an amino acid sequence having at least 95% identity with SEQ ID NO: 1, and the effective amount of beta-lactamase is between about 5 and about 200 mg. ### Claim 2 (depends on 1) The method of claim 1, wherein the effective amount of beta-lactamase is about 150 mg ### Claim 3 (depends on 1) The method of claim 1, wherein the patient is undergoing treatment with a proton pump inhibitor. ### Claim 4 (depends on 1) The method of claim 1, wherein the beta-lactam antibiotic is a penicillin ### Claim 5 (canceled) ### Claim 6 (depends on 1) The method of claim 1, wherein the beta-lactam antibiotic is a cephalosporin. ### Claim at position 7 7-8. (canceled) ### Claim 9 (depends on 1) The method of claim 1, wherein the beta-lactamase comprises an amino acid sequence having at least 97% identity with SEQ ID NO: 1. ### Claim 10 (canceled) ### Claim 11 (depends on 1) The method of claim 1, wherein the beta-lactamase comprises an amino acid sequence having at least 99% identity with SEQ ID NO: 1. ### Claim 12 (depends on 1) The method of claim 1, wherein the beta-lactamase comprises an amino acid sequence of SEQ ID NO: 1. ### Claim 13 (depends on 1) The method of claim 1, wherein the beta-lactam antibiotic and beta-lactamase are administered simultaneously. ### Claim 14 (depends on 1) The method of claim 1, wherein the beta-lactam antibiotic and beta-lactamase are administered sequentially. ### Claim at position 14 15-16. (canceled) ### Claim 17 (depends on 1) The method of claim 1, wherein the beta-lactamase is administered orally. ### Claim 18 (depends on 1) The method of claim 1, wherein the beta-lactam antibiotic is administered parenterally, optionally selected from intravenously and/or by infusion. ### Claim at position 17 19-25. (canceled) ### Claim 26 (depends on 1) The method of claim 1, wherein the method further comprises administering an agent that modulates GI tract pH. ### Claim 27 (depends on 26) The method of claim 26, wherein the agent that modulates GI tract pH is a proton pump inhibitor. ### Claim 28 (depends on 1) The method of claim 1, wherein the protection of the patient's microbiome comprises treatment or prevention of a microbiome-mediated disorder. ### Claim 29 (depends on 28) The method of claim 28, wherein the microbiome-mediated disorder is selected from antibiotic-induced adverse effect, C. difficile infection (CDI), C. difficile-associated disease, ulcerative colitis, Crohn's disease, irritable bowel syndrome, fatty liver disease, obesity, Parkinson's disease, autism, depression, immune-mediated disorders, metabolic disorders, chronic fatigue syndrome, or any disorder associated with an imbalance of the gut microbiome. ### Claim 30 (depends on 29) The method of claim 29, wherein the microbiome-mediated disorder is one or more of an antibiotic-induced adverse effect, C. difficile infection (CDI), and a C. difficile-associated disease. ### Claim 31 (depends on 30) The method of claim 30, wherein the antibiotic-induced adverse effect and/or CDI or C. difficile-associated disease is one or more of: antibiotic-associated diarrhea, C. difficile diarrhea (CDD), C. difficile intestinal inflammatory disease, colitis, pseudomembranous colitis, fever, abdominal pain, dehydration and disturbances in electrolytes, megacolon, peritonitis, and perforation and/or rupture of the colon. ### Claim 32 (depends on 1) The method of claim 1, wherein the protection of the patient's microbiome comprises maintenance of a normal intestinal microbiota, such as a healthy microbiota balance (e.g. a healthy ratio and/or distribution). ### Claim 33 (depends on 1) The method of claim 1, wherein the method treats and/or prevents the overgrowth of one or more pathogenic microorganisms in the GI tract of a patient. ### Claim at position 26 34-57. (canceled)