Methods and compositions for the treatment of C. difficile
Inventors
FARQUHAR, RONALD • Murphy, Christopher K. • Hill, Colin • Ross, Paul • Rea, Mary • O'DONNELL, MICHELLE • Healy, Brian • CHESNEL, LAURENT
Assignees
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Publication Number
US-11419900-B2
Publication Date
2022-08-23
Expiration Date
Abstract
Disclosed herein are compositions and methods for preventing, ameliorating, or treating Clostridium difficile infections and/or reducing the severity of one or more risk factors, signs, or symptoms associated with C. difficile infections. In particular, the technology of the present disclosure relates to methods for administering an effective amount of a composition comprising strains of Bacillus amyloliquefaciens bacteria identified as ART24, ART4, and ART 12, to a subject suffering from or at risk for C. difficile infections.
Core Innovation
The disclosed invention provides a probiotic/live biotherapeutic platform based on one or more bacterial strains selected from ART24 (NCIMB Accession No. 43088), ART4 (NCIMB Accession No. 43086), and ART12 (NCIMB Accession No. 43087). The platform is formulated as vegetative cells and/or spores and includes a preservative/cryoprotectant for maintaining the bacterial composition.
A core aspect of the invention is using the specified Bacillus amyloliquefaciens strains to treat or prevent Clostridium difficile infection or a Clostridium difficile-associated disease (CDAD) in a subject in need thereof. The documented scope also extends treatment or prevention to Clostridium perfringens infection and Listeria monocytogenes infection, and further includes Vibrio parahaemolyticus infection.
The invention further characterizes antimicrobial/toxin-related activity of the platform, including anti-C. difficile activity and toxin cleavage activity for toxin A and toxin B. The disclosure also addresses formulation robustness and exposure contexts, including lyophilization and simulated gastric conditions, and reports in vivo efficacy in a mouse model, as well as activity across multiple clinical isolates.
Claims Coverage
The provided independent claims are clm-00001, clm-00012, and clm-00024. Across these claims, the coverage centers on three inventive feature groups: a specific bacterial composition with a preservative, a treatment/prevention method for specified infections by administering that composition, and an extended treatment/prevention method for Vibrio parahaemolyticus with context-specific use cases.
Specific bacterial composition with preservative
A composition comprising one or more bacterial strains selected from ART24 (NCIMB Accession No. 43088), ART4 (NCIMB Accession No. 43086), and ART12 (NCIMB Accession No. 43087), and a preservative.
Administering specified ART bacterial strains for treatment or prevention of selected diseases or conditions
A method for treating or preventing one or more diseases or conditions selected from Clostridium difficile infection or a Clostridium difficile-associated disease (CDAD), Clostridium perfringens infection, and Listeria monocytogenes infection in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising one or more bacterial strains selected from ART24 (NCIMB Accession No. 43088), ART4 (NCIMB Accession No. 43086), and ART12 (NCIMB Accession No. 43087).
Administering specified ART bacterial strains for Vibrio parahaemolyticus infection
A method for treating or preventing a Vibrio parahaemolyticus infection in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising one or more bacterial strains selected from ART24 (NCIMB Accession No. 43088), ART4 (NCIMB Accession No. 43086), and ART12 (NCIMB Accession No. 43087).
Overall claim coverage protects: (i) a composition containing one or more of ART24/ART4/ART12 with a preservative, and (ii) therapeutic methods that administer a therapeutically effective amount of that composition to treat or prevent the enumerated infections, including an additional method focused on Vibrio parahaemolyticus.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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