Methods of treatment using single doses of oritavancin
Inventors
Lehoux, Dario • Parr, Thomas R. • Moeck, Gregory • Etienne, Pierre
Assignees
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Publication Number
US-12514899-B2
Publication Date
2026-01-06
Expiration Date
Abstract
Glycopeptide antibiotics, such as oritavancin, demonstrate significant activity against a wide range of bacteria. Methods for the treatment, prophylaxis and prevention of bacterial infection and disease in animals, including humans, using a single dose of oritavancin over the course of therapy, are described.
Core Innovation
The invention relates to oritavancin regimens for treating, prophylaxing, and preventing bacterial infections in a human subject, with clinically significant efficacy enabled by prolonged plasma half-life. The regimens include administering a single dose of a therapeutically effective amount of a pharmaceutical composition comprising oritavancin, or a pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable carrier or diluent, over a course of therapy.
The disclosed methods specifically cover bacterial infections caused by Streptococcus dysgalactiae. In described variations, the therapy is associated with single-dose administration and can include an optional second dose within a course of therapy, with the second dose being delayed in the variations.
Routes of administration include intravenous administration and oral administration, and the infection scope includes complicated and uncomplicated skin and soft tissue infections. The patent provides supporting data for clinically relevant cure outcomes using a phase 2 randomized study in complicated skin and skin structure infection (cSSSI), and includes preclinical mouse thigh infection and pharmacokinetic analyses to support dose-dependent efficacy and exposure consistent with single-dose regimens.
Claims Coverage
The partial content provides two independent claims, each directed to a method of treating a bacterial infection in a human subject using a single-dose oritavancin regimen for infections caused by Streptococcus dysgalactiae. Across the independent claims, the main inventive coverage is a single-dose therapeutic method with a minimum or specified dose of oritavancin.
Single-dose oritavancin treatment for Streptococcus dysgalactiae infection
A method of treating a bacterial infection in a human subject comprising administering a single dose of a therapeutically effective amount of a pharmaceutical composition comprising oritavancin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent over a course of therapy, wherein the bacteria causing the bacterial infection is Streptococcus dysgalactiae, thereby treating a bacterial infection in the subject.
At least 1200 mg single-dose oritavancin
The method wherein the single dose comprises at least 1200 mg oritavancin, or a pharmaceutically acceptable salt thereof, administered to a human subject having a bacterial infection caused by Streptococcus dysgalactiae.
About 1200 mg single-dose oritavancin treatment for Streptococcus dysgalactiae infection
A method of treating a bacterial infection in a human subject comprising administering a single dose of a therapeutically effective amount of a pharmaceutical composition comprising oritavancin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent over a course of therapy, wherein the single dose comprises about 1200 mg oritavancin, or a pharmaceutically acceptable salt thereof, and wherein the bacteria causing a bacterial infection is Streptococcus dysgalactiae, thereby treating a bacterial infection in the subject.
Overall, the independent claims cover treating Streptococcus dysgalactiae bacterial infections in humans using a single-dose oritavancin pharmaceutical composition delivered over a course of therapy, with the single dose meeting either at least 1200 mg or being about 1200 mg.
Stated Advantages
Clinically significant efficacy enabled by prolonged plasma half-life.
Clinical cure rates supported by phase 2 randomized study in cSSSI.
Documented Applications
Treating a bacterial infection in a human subject caused by Streptococcus dysgalactiae.
Prophylaxing and preventing bacterial infections in a human subject.
Treatment across skin and skin structure infection scope, including complicated and uncomplicated skin and soft tissue infections (SSTI), with supporting phase 2 randomized study in cSSSI.
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