# US 2025/0146074 A1 · Determining whether an ibd patient will respond to 5-asa therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0146074 A1 - Document ID: US20250146074A1 - Status: Published application - Kind: A1 - Application number: 18/939,874 - Filed: 2024-11-07 - Published: 2025-05-08 - Earliest claimed: 2023-11-07 - Assignees: The General Hospital Corporation; President and Fellows of Harvard College; The Brigham and Womens's Hospital, Inc. - Applicants: The General Hospital Corporation; President and Fellows of Harvard College; The Brigham and Womens's Hospital, Inc. - Inventors: Raaj S. Mehta; Curtis Huttenhower; Andrew T. Chan; Jared R. Mayers; Emily Balskus - Web page: https://patentgrep.com/patent/US20250146074A1 ## CPC - C12Q 1/6883: for diseases caused by alterations of genetic material - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 31/52: Purines, e.g. adenine - A61K 31/606: having amino groups - C07K 16/241: {Tumor Necrosis Factors} - C07K 16/2842: {against integrin beta1-subunit-containing molecules, e.g. CD29, CD49} - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism - C12Q 2600/158: Expression markers - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - 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) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract The invention relates to a method of determining whether a patient diagnosed with inflammatory bowel disease (will respond to 5-ASA therapy which includes the steps of: obtaining a stool sample from the patient, analyzing the sample for the presence of microbial acetyltransferase genes capable of converting 5-ASA to the clinically ineffective N-acetyl 5-ASA, if microbial acetyltransferase genes are not present in the sample, the patient will respond to 5-ASA therapy and such therapy should be administered; if microbial acetyltransferase genes are present in the sample, the patient will not respond to 5-ASA therapy and a second line therapy should be administered. ## Claims ### Claim 1 A method of determining whether a patient diagnosed with inflammatory bowel disease (IBD) will respond to 5-ASA therapy, the method comprising: (a) obtaining a stool sample from the patient, (b) analyzing the sample for the presence of microbial acetyltransferase genes capable of converting 5-ASA to the clinically ineffective N-acetyl 5-ASA, (c) if microbial acetyltransferase genes are not present in the sample, the patient will respond to 5-ASA therapy and such therapy should be administered; if microbial acetyltransferase genes are present in the sample, the patient will not respond to 5-ASA therapy and a second line therapy should be administered. ### Claim 2 (depends on 1) The method according to claim 1, wherein the microbial acetyltransferase genes are three or more of the following genes: R6CZ24—“Acetyl-CoA acetyltransferase” from Firmicutes bacterium CAG:176 T5S060—“Acetyl-CoA C-acetyltransferase” from Ruminococcaceae bacterium D16 R5CY66—“Acetyl-CoA acetyltransferase” from Firmicutes bacterium CAG:83 C7H1G6—“Acetyltransferase, GNAT family” from Faecalibacterium prausnitzii. ### Claim 3 (depends on 1) The method of claim 1, wherein IBD is ulcerative colitis. ### Claim 4 (depends on 1) The method of claim 1, wherein IBD is Crohn's Disease. ### Claim 5 (depends on 1) The method of claim 1, wherein the second line therapy is selected from a biologic for treating IBD. ### Claim 6 (depends on 1) The method of claim 1, wherein the second line therapy is selected from an immunomodulator for treating IBD. ### Claim 7 (depends on 1) The method of claim 1, wherein analyzing comprises qPCR. ### Claim 8 A method for treating a patient having IBD comprising administering to the patient a biologic in an amount effective to treat IBD when a stool sample from the patient comprises microbial acetyltransferase genes capable of converting 5-ASA to N-acetyl 5-ASA. ### Claim 9 (depends on 8) The method of claim 8, wherein IBD is ulcerative colitis. ### Claim 10 (depends on 8) The method of claim 8, wherein IBD is Crohn's Disease. ### Claim 11 (depends on 8) The method of claim 8, wherein the biologic for treating IBD is adalimumab, vedolizumab, or infliximab. ### Claim 12 A method for treating a patient having IBD comprising administering to the patient an immunomodulator in an amount effective to treat IBD when a stool sample from the patient comprises microbial acetyltransferase genes capable of converting 5-ASA to N-acetyl 5-ASA. ### Claim 13 (depends on 12) The method of claim 12, wherein IBD is ulcerative colitis. ### Claim 14 (depends on 12) The method of claim 12, wherein IBD is Crohn's Disease. ### Claim 15 (depends on 12) The method of claim 12, wherein the immunomodulator for treating IBD is 6-mercaptopurine or tofacitinib. ### Claim 16 A method for treating a patient having IBD comprising administering to the patient 5-aminosalicylic acid (5-ASA) in an amount effective to treat IBD when microbial acetyltransferase genes are not present in a stool sample from the patient. ### Claim 17 (depends on 16) The method of claim 16, wherein IBD is ulcerative colitis. ### Claim 18 (depends on 16) The method of claim 16, wherein IBD is Crohn's Disease. ### Claim 19 (depends on 16) The method according to claim 16, wherein the microbial acetyltransferase genes are three or more of the following genes: R6CZ24—“Acetyl-CoA acetyltransferase” from Firmicutes bacterium CAG:176 T5S060—“Acetyl-CoA C-acetyltransferase” from Ruminococcaceae bacterium D16 R5CY66—“Acetyl-CoA acetyltransferase” from Firmicutes bacterium CAG:83 C7H1G6—“Acetyltransferase, GNAT family” from Faecalibacterium prausnitzii. ### Claim 20 (depends on 16) The method of claim 16, wherein analyzing for the presence or absence of microbial acetyltransferase genes comprises qPCR.