Methods and compositions for treating gastrointestinal and inflammatory disorders

A technology of composition and mixture, applied in the field of mesalamine and cortex

Pending Publication Date: 2021-11-30
XBIOME INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, a large number of patients with mildly to moderately active UC do not respond adequately to first-line therapy with mesalamine alone, necessitating the introduction of more toxic immunosuppressive drugs

Method used

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  • Methods and compositions for treating gastrointestinal and inflammatory disorders
  • Methods and compositions for treating gastrointestinal and inflammatory disorders
  • Methods and compositions for treating gastrointestinal and inflammatory disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0176] Example 1 - Overview of Bacterial Strain Selection Process for Mixed Flora 1 (C1)

[0177] Mixed flora 1 (C1), a drug developed for the treatment of gastrointestinal disorders such as dysbiosis and / or immune-mediated inflammatory diseases such as ulcerative colitis, Crohn's disease and other forms of inflammatory Intestinal Diseases (IBD)) containing a mixed flora of three bacterial strains, Bacteroides polymorpha BTH01, Eubacterium hallii EHA01 and Rothia hominis RHO01.

[0178] Candidate strains of interest were isolated, purified, and characterized from healthy donor fecal samples using standard anaerobic microbiological procedures. All stool donors undergo comprehensive clinical and laboratory testing to confirm health status, including screening for infectious agents, to minimize the risk of transmissible infection. Serological screening includes HIV-1 / HIV-2 (IgG and EIA), HTLY-1 and HTLY-II (Ab), hepatitis A virus (IgM), hepatitis B virus (HBSAg, anti-HBc IgG and I...

Embodiment 2-C1

[0181] Taxonomic and phenotypic characterization of Example 2-C1 bacterial strains

[0182] Live biotherapeutic product mixed population 1 (C1 ) was prepared by mixing three bacterial strains, namely BTH01, EHA01 and RHO01. Table 1 shows some physiological and metabolic characteristics of the C1 bacterial strains BTH01, EHA01 and RHO01. Gram staining of the three C1 bacterial strains showed that EHA01 was Gram-positive, whereas both BTH01 and RHO01 were Gram-negative. All three strains were obligate anaerobes.

[0183] To investigate a feature that is often found to be different among strains of the same bacterial species, a carbon source utilization analysis was performed on the C1 bacterial strain. The ability of BTH01, EHA01 and RHO01 strains to metabolize 190 carbon sources and 95 nitrogen sources was assessed using phenotypic microarrays (Biolog, Hayward, CA). As shown in Table 1, BTH01 appears to be the most versatile, utilizing 34 unique carbon sources, while EHA01 i...

Embodiment 3-C1

[0204] Whole Genome Sequencing (WGS) Analysis of Example 3-C1 Bacterial Strains

[0205] Genome analysis of each bacterial strain (BTH01, EHA01 and RHO01) was carried out WGS to confirm taxonomic identity and to assess genomic evidence for the presence of antibiotic resistance genes, virulence factors, and toxins, including evidence of associated mobile genetic elements.

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PUM

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Abstract

The disclosure relates generally to bacterial strains and bacterial strain mixtures, e.g., Eubacterium, Bacteroides, and Roseburia bacterial strains and mixtures thereof. The disclosure further relates to methods of using bacterial strains and bacterial strain mixtures for treating a gastrointestinal disorder, e.g, ulcerative colitis, an inflammatory disorder, and / or dysbiosis.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Patent Application Serial No. 62 / 730,792 filed September 13, 2018, U.S. Provisional Patent Application Serial No. 62 / 734,495 filed September 21, 2018, U.S. Provisional Patent Application Serial No. 62 / 734,495 filed October 18, 2018 Benefit and Priority of Application Serial No. 62 / 747,391 and U.S. Provisional Patent Application Serial No. 62 / 782,666, filed December 20, 2018. [0003] sequence listing [0004] This application contains a Sequence Listing that has been filed electronically in ASCII format, the entire contents of which are hereby incorporated by reference. The ASCII copy created on December 19, 2018 is named ASP-056_SL.txt and is 17,078,089 bytes in size. Background technique [0005] The gastrointestinal tract (GI) and other organ systems are complex biological systems that include communities of many different organisms, including different strains of bacteria. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N1/20A61K35/741A61K35/74A61P1/00A61P29/00C12R1/01
CPCA61K35/74C12N1/20C12R2001/01C12N1/205A61P1/00A61K35/742A61K2300/00A61P1/04A61K35/741A61K47/26
Inventor J·帕普科夫马俊
Owner XBIOME INC
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