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-10350250-B2
Publication Date
2019-07-16
Expiration Date
Abstract
Provided herein are compositions and methods for the treatment or prevention of pathogenic infections.
Core Innovation
The invention provides a pharmaceutical composition containing a purified bacterial mixture consisting of 7 bacterial strains. Each bacterial strain is defined by 16S rDNA sequences with at least 97% sequence identity to nucleic acid sequences selected from specified SEQ ID NOs, and the bacterial strains are lyophilized.
The disclosure further describes sequence identification support using 16S rDNA sequence identification, homology or identity metrics, corresponding GenBank accessions, and whole-genome sequencing homology tables linking composition strains to closest species. It also includes strain support using Sanger-validated 16S consensus sequences and explicit 16S rDNA nucleotide sequences for multiple strains.
The patent also provides formulation and targeting language adjacent to the sequence data, including pharmaceutically acceptable excipient and colon delivery using enteric polymers. The compositions and uses are described in the context of preventing and treating Clostridium difficile infection (CDI), and administration to treat pathogenic infections.
Claims Coverage
The independent claims cover 2 core inventive features: a purified bacterial mixture of exactly 7 strains defined by specified SEQ ID NO-based 16S rDNA identity, and lyophilized bacterial strains.
Purified bacterial mixture of 7 16S-defined strains
A pharmaceutical composition comprising a purified bacterial mixture consisting of 7 bacterial strains comprising 16S rDNA sequences of at least 97% sequence identity to nucleic acid sequences selected from SEQ ID NO:10, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21.
Lyophilized bacterial strains
The bacterial strains are lyophilized.
The claim coverage centers on a purified bacterial mixture of exactly 7 bacterial strains, each defined by specified SEQ ID NO-based 16S rDNA identity of at least 97%, with the additional requirement that the strains are lyophilized.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Administration to treat pathogenic infections, including C. difficile.
Preventing Clostridium difficile infection (CDI).
Treating Clostridium difficile infection (CDI).
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