Dosing regimens for echinocandin class compounds
Inventors
Radhakrishnan, Balasingam • James, JR., Kenneth Duke • Vaidya, Anuradha • Polowy, Karen
Assignees
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Publication Number
US-10702573-B2
Publication Date
2020-07-07
Expiration Date
Abstract
The invention features pharmaceutical compositions, methods, and kits featuring dosing gimens and oral dosage formulations for administration of echinocandin class compounds.
Core Innovation
The invention relates to treating a subject having or susceptible to a fungal infection by administering an aqueous solution comprising compound 22 or a pharmaceutically acceptable salt thereof. The treatment uses intravenous administration at an interval of one dose every 5 to 8 days, in an amount sufficient to treat the fungal infection.
The disclosure concerns echinocandin-class antifungal drugs and dosing regimens that emphasize reduced dosing frequency. The disclosed dosing concepts include loading-dose regimen structures and maintenance dosing consistent with the stated interval-based treatment framework.
The disclosure defines echinocandin-class compounds by specifying multiple generic formulas, including formula (VI), formula (VII) variants, formula (VIII) variants, and formula (IX), with allowable substituents and pharmaceutically acceptable salts. It provides structural definitions for compound embodiments, including compound 22 and compounds 1-46, and includes quaternized amine groups, PEG-containing groups, and solubilizing substituent motifs.
The disclosure further describes oral dosage formulations to increase oral bioavailability of echinocandin-class compounds, including enhancer additives such as acyl carnitines, saccharides, ester saccharides, surfactants, bile acids, chitosan, PEG derivatives, alkyl/ester saccharides, amido fatty acids, ammonium sulfonate surfactants, phospholipids, PEGylated materials, PEG-alkyl ethers, polyglycolized glycerides, polyglycerol fatty acid esters, polysorbate surfactants, taste-masked formulation components, and ion pairing agents.
Claims Coverage
The claim coverage centers on one independent claim for treating a subject having or susceptible to a fungal infection by intravenous administration of an aqueous solution containing compound 22 or a pharmaceutically acceptable salt. The claim set includes 6 inventive features, with dependent claims refining the dosing interval, treatment duration, and salt identity.
Intravenous aqueous solution of compound 22
Administering an aqueous solution comprising compound 22 or a pharmaceutically acceptable salt thereof to a subject having or susceptible to a fungal infection.
Dosing interval every 5 to 8 days
The aqueous solution is administered intravenously at an interval of one dose every 5 to 8 days, in an amount sufficient to treat the fungal infection.
Interval every 7 days
The dosing interval is one dose every 7 days.
Multi-interval administration over at least two weeks
An aqueous solution is administered intravenously over at least two intervals across a period of at least two weeks.
Minimum treatment duration of at least twelve weeks
The aqueous solution is intravenously administered for at least twelve weeks.
Acetate pharmaceutically acceptable salt
The pharmaceutically acceptable salt of compound 22 is an acetate salt.
Across the claim set, the inventive coverage centers on intravenous administration of an aqueous solution containing compound 22 or a pharmaceutically acceptable salt for treatment of fungal infection, using a one-dose-every-5-to-8-days schedule. Dependent claims narrow the interval to 7 days, require at least two intervals over at least two weeks, require at least twelve weeks of administration, and specify an acetate salt.
Stated Advantages
Reduced dosing frequency for treating fungal infection using interval-based intravenous administration.
Increase oral bioavailability of echinocandin-class compounds.
Higher aqueous solubility and greater stability.
Documented Applications
Treating a subject having or susceptible to a fungal infection using an aqueous solution comprising compound 22 administered intravenously at specified intervals.
Treatment of subject populations characterized by having an invasive medical procedure selected from transplant, stem cell therapy, graft, prosthesis implantation, intravenous catheterization, or intensive care unit treatment.
Treatment of fungal infections.
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