Treatment of clostridium difficile infection
Inventors
Schneider, Jessica • Kim, Yun-gi • Olle, Bernat • Reddy, Shilpa • Norman, Jason • Patarroyo, Juan
Assignees
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Publication Number
US-10456431-B2
Publication Date
2019-10-29
Expiration Date
Abstract
Provided herein are compositions and methods for the treatment or prevention of pathogenic infections.
Core Innovation
The invention relates to pharmaceutical compositions comprising a purified bacterial mixture. The purified bacterial mixture consists of bacterial strains comprising 16S rDNA sequences of at least 97% sequence identity to specified SEQ ID NOs, and the composition further comprises one or more enteric polymers and is provided in the form of a capsule.
The pharmaceutical composition comprises between 1×10^7 and 1×10^10 colony forming units (CFUs) per bacterial strain. The disclosed bacterial mixtures are described as purified multi-strain bacterial mixtures and can include bacterial strains that are spore-formers and strains that come from more than one human donor, together with pharmaceutically acceptable excipients.
The compositions are formulated for oral administration and for delivery to the colon using a pH-sensitive composition. The document also states that administering the compositions can treat infectious disease, including Clostridium difficile infection, and relates to treatment and prevention of Clostridium difficile infection.
Claims Coverage
The document includes one independent claim directed to a pharmaceutical composition defined by purified multi-strain 16S rDNA identity criteria, one or more enteric polymers, a defined CFU range per bacterial strain, and capsule form. Dependent claims further refine bacterial characteristics, sourcing, excipients, and oral or colon delivery; 8 inventive features are identified.
Purified multi-strain bacterial mixture defined by 16S rDNA identity criteria
A pharmaceutical composition comprising a purified bacterial mixture consisting of bacterial strains comprising 16S rDNA sequences of at least 97% sequence identity to specified SEQ ID NOs.
Combination with one or more enteric polymers
The pharmaceutical composition comprises one or more enteric polymers together with the purified bacterial mixture.
Defined dosing in capsule form
The pharmaceutical composition comprises between 1×10^7 and 1×10^10 colony forming units (CFUs) per bacterial strain and is provided in the form of a capsule.
Spore-former bacterial strains
The pharmaceutical composition further includes bacterial strains that are spore-formers.
Bacterial strains from more than one human donor
The pharmaceutical composition includes bacterial strains that come from more than one human donor.
Inclusion of a pharmaceutically acceptable excipient
The pharmaceutical composition further includes a pharmaceutically acceptable excipient.
Oral administration formulation
The pharmaceutical composition is formulated for oral administration.
Delivery to the colon formulation
The pharmaceutical composition is formulated for delivery to the colon.
Overall, the claim set defines a capsule pharmaceutical composition containing a purified multi-strain bacterial mixture characterized by at least 97% 16S rDNA identity to specified SEQ ID NOs, formulated with one or more enteric polymers and a defined CFU range, with dependent claim refinements to spore formers, donor sourcing, pharmaceutically acceptable excipients, and oral or colon delivery.
Stated Advantages
Treats infectious disease, including Clostridium difficile infection.
Documented Applications
Therapeutic use against pathogenic infections including C. difficile, with toxin B context.
Formulation for oral delivery using enteric polymers and capsule for colon delivery.
Treatment of infectious disease, including Clostridium difficile infection.
Treatment and prevention of Clostridium difficile infection.
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