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Publication Number
US-11779617-B2
Publication Date
2023-10-10
Expiration Date
Abstract
The present invention relates to bacteriophage therapy. More particularly, the present invention relates to novel bacteriophages having a high specificity against Pseudomonas aeruginosa strains, their manufacture, components thereof, compositions comprising the same and the uses thereof in phage therapy.
Core Innovation
The invention relates to novel lytic, highly specific Pseudomonas aeruginosa bacteriophages selected from environmental samples and linked to defined SEQ ID NOs. It presents specific bacteriophages including BP1384, BP1777, BP1792, BP1797, BP1800, BP1902, and BP1940, where the selected bacteriophages are characterized by genome nucleotide sequences identified by the SEQ ID NOs.
The invention addresses the problem of providing antibacterial bacteriophage compositions with lytic activity against P. aeruginosa strains, including antibiotic-resistant and ESBL-associated strains, while maintaining high specificity. The described phage cocktails are stated to broadly lyse or kill P. aeruginosa, including cystic-fibrosis antibiotic-resistant strains, and to show no lysis of non-P. aeruginosa bacteria.
The invention further defines antibacterial phage compositions and example cocktail combinations, including kinetic and activity-related parameters such as burst size and productive lytic effect. It also describes predictive and efficacy testing based on measuring lytic activity against patient isolates and reports experimental data demonstrating high % kill and efficiency at low MOI against cystic-fibrosis antibiotic-resistant strains. Formulations are described, including lyophilized formulations, and preservative-containing pharmaceutically acceptable excipients are used to preserve bacteriophage activity.
Claims Coverage
The independent claims cover four inventive areas: an antibacterial phage composition, methods of treating a mammalian infection, methods for improving a mammal by modifying microbial flora, and methods for decontaminating a material. Across these independent claims, the inventive features are built around lytic activity against Pseudomonas aeruginosa and selection of bacteriophages by genome content.
Lytic bacteriophage antibacterial composition with genome-defined selection and preservative carrier
An antibacterial composition comprising at least one bacteriophage having lytic activity against Pseudomonas aeruginosa strain and a pharmaceutically acceptable excipient or carrier, wherein said at least one bacteriophage is selected from bacteriophages having a genome comprising a nucleotide sequence of any one of SEQ ID NOs: 2 to 7 or a sequence having at least 99% identity thereto, and wherein said pharmaceutically acceptable excipient or carrier comprises a preservative in an amount effective to preserve the activity of the bacteriophage.
Treating a mammalian infection with genome-defined lytic bacteriophage composition
A method of treatment of an infection in a mammal in need thereof comprising contacting the mammal with an effective amount of an antibacterial composition, wherein said composition comprises at least one bacteriophage having lytic activity against a Pseudomonas aeruginosa strain, said at least one bacteriophage being selected from the bacteriophages having a genome comprising any one of SEQ ID NOs: 2 to 7 or a sequence having at least 99% identity thereto.
Improving a mammal condition by modifying microbial flora using genome-defined lytic bacteriophage composition
A method for improving the condition of a mammal by modifying the microbial flora in said mammal comprising contacting the mammal with an effective amount of an antibacterial composition, wherein said composition comprises at least one bacteriophage having lytic activity against a Pseudomonas aeruginosa strain, said at least one bacteriophage being selected from the bacteriophages having a genome comprising any one of SEQ ID NOs: 2 to 7 or a sequence having at least 99% identity thereto.
Decontaminating a material with genome-defined lytic bacteriophage composition
A method for decontaminating a material, comprising exposing the material to an effective amount of an antibacterial composition, wherein said composition comprises at least one bacteriophage having lytic activity against a Pseudomonas aeruginosa strain, said at least one bacteriophage being selected from the bacteriophages having a genome comprising any one of SEQ ID NOs: 2 to 7 or a sequence having at least 99% identity thereto.
Across the independent claims, protection is directed to antibacterial compositions and uses in treatment, microbial flora modification, and material decontamination, each requiring lytic activity against Pseudomonas aeruginosa and selection of the bacteriophage by genome nucleotide sequences corresponding to SEQ ID NOs: 2 to 7 or sequences with at least 99% identity.
Stated Advantages
Broad lysis or killing of P. aeruginosa, including antibiotic-resistant and ESBL-associated strains.
Highly specific lytic activity showing no lysis of non-P. aeruginosa bacteria.
Predictive and efficacy testing based on measuring lytic activity against patient isolates.
High % kill and efficiency at low MOI against cystic-fibrosis antibiotic-resistant strains.
Documented Applications
Treating an infection in a mammal, including respiratory tract infections as indicated by dependent claim language.
Improving the condition of a mammal by modifying the microbial flora.
Decontaminating a material by exposing it to the antibacterial composition.
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