Compositions and methods for inhibiting the proliferation of enterotoxigenic bacteroides fragilis
Inventors
Yoon, Seong Jun • Son, Jee Soo • KIM, In Hwang • Paik, Hyoung Rok • OH, Eun Kyoung • JUN, Soo Youn • Kang, Sang Hyeon
Assignees
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Publication Number
US-12274721-B2
Publication Date
2025-04-15
Expiration Date
Abstract
A composition for preventing or treating an infection or disease caused by enterotoxigenic Bacteroides fragilis includes a Siphoviridae bacteriophage (Bac-FRP-4) having an ability to lyse the enterotoxigenic Bacteroides fragilis cells and a pharmaceutically acceptable carrier. A method for preventing or treating an infection or disease caused by enterotoxigenic Bacteroides fragilis includes administering to a subject a Siphoviridae bacteriophage and lysing the enterotoxigenic Bacteroides fragilis cells by the Siphoviridae bacteriophage.
Core Innovation
The invention relates to preventing or treating an infection or disease caused by enterotoxigenic Bacteroides fragilis by administering a composition containing a Siphoviridae bacteriophage Bac-FRP-4. Bac-FRP-4 is described as lyse-capable for enterotoxigenic Bacteroides fragilis cells, and its genome sequence is set forth in SEQ ID NO: 1. The bacteriophage is deposited in the Korean Collection for Type Culture under accession number KCTC 14402BP.
The Bac-FRP-4 used in the composition is further characterized by a latent period of 10–100 minutes and a burst size of 580–800 plaque-forming units per infected cell. The bacteriophage is also characterized by structural proteins with sizes of approximately 25 kDa, 42 kDa, 48 kDa, and 65 kDa. The invention defines a specific concentration range of Bac-FRP-4 in the composition.
The invention is directed to the problem of infection or disease caused by enterotoxigenic Bacteroides fragilis and is addressed through administration of a Bac-FRP-4 composition. Documented compositions and methods are described as supporting prevention and treatment outcomes in relevant in vivo models, including diarrhea-related outcomes.
Claims Coverage
The patent includes one independent claim covering a method of preventing or treating an infection or disease caused by enterotoxigenic Bacteroides fragilis. Three inventive features are identified across the claims, with dependent claims mainly adding or narrowing pharmaceutical carrier and excipient selections, indication scope, and dosage form options.
Preventing or treating ETBF infection or disease with Bac-FRP-4 composition
Administering to a subject a composition containing Siphoviridae bacteriophage Bac-FRP-4 and a pharmaceutically acceptable carrier, where the Bac-FRP-4 is deposited as KCTC 14402BP, has an ability to lyse enterotoxigenic Bacteroides fragilis cells, and has a genome sequence as set forth in SEQ ID NO: 1.
Bac-FRP-4 kinetic and structural profile for the composition
Using Siphoviridae bacteriophage Bac-FRP-4 having a latent period of 10–100 minutes and a burst size of 580–800 PFU/infected cell, and having structural proteins in the size of approximately 25 kDa, 42 kDa, 48 kDa, and 65 kDa.
Defined Bac-FRP-4 concentration range in the composition
Providing the composition with a concentration of Siphoviridae bacteriophage Bac-FRP-4 of 1×10^4 PFU/ml to 1×10^15 PFU/ml or 1×10^4 PFU/g to 1×10^15 PFU/g.
Overall, claim coverage is centered on administering a pharmaceutically acceptable composition containing the specifically deposited Bac-FRP-4, with defined genome information, lyse-capability against enterotoxigenic Bacteroides fragilis, specified latent period and burst size, specified structural protein sizes, and a defined PFU concentration range.
Stated Advantages
High ETBF specificity versus antibiotics.
Documented Applications
Prevention of diarrhea-related outcomes in a weaning pigs animal model using a Bac-FRP-4 composition.
Treatment in a mouse survival model with improved diarrhea outcomes using a Bac-FRP-4 composition.
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