Minocycline compounds and methods of use thereof
Inventors
Johnston, Sean M. • Arbeit, Robert D. • Bigger, Thomas J. • Molnar, Dennis P. • Tanaka, S. Ken
Assignees
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Publication Number
US-10124014-B2
Publication Date
2018-11-13
Expiration Date
Abstract
Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof.
Core Innovation
A tetracycline compound, 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline (compound 1), is disclosed for use with pharmaceutically acceptable salts, including hydrochloride and tosylate, for treating bacterial infections in a human subject. The disclosure connects the compound to treatment of complicated Skin and Skin Structure Infections (CSSSI).
The problem addressed is bacterial infections, including infections caused by MSSA, MRSA, β-hemolytic streptococci, Viridans streptococci, Enterococcus, gram-negative rods, gram-negative bacteria, and gram-positive anaerobes, in the clinical setting of CSSSI. The disclosures frame the need for treatment outcomes and tolerability, including gastrointestinal (GI) adverse events, associated with administration of an effective amount of the compound 1.
The disclosed invention is characterized by dosing and regimen structures in CSSSI using intravenously administering compound 1 or a salt to achieve treatment while maintaining mild gastrointestinal adverse events. In another aspect, the disclosure includes an intravenous-to-oral step-down regimen in which compound 1 is administered intravenously for about 2–6 days followed by an oral administration, with a total treatment period of about 8–12 days.
Claims Coverage
The provided independent claims cover two main method variants for CSSSI using the same tetracycline compound 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline, or a salt, with gastrointestinal adverse events characterized as mild. Across the independent claims, the coverage focuses on intravenously administering the compound alone with specified maximum treatment durations and an intravenous-to-oral step-down regimen with specified IV and total treatment periods.
Intravenous treatment of CSSSI with mild GI adverse events within specified day limits
A method of treating a human subject for complicated Skin and Skin Structure Infections by intravenously administering an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that the subject is treated, wherein gastrointestinal adverse events associated with treatment are mild, and wherein the subject is treated up to and including about 14 days, about 10 days, about 9 days, about 8 days, or about 7 days.
IV-to-oral step-down CSSSI regimen with mild GI adverse events
A method of treating a human subject for complicated Skin and Skin Structure Infections by intravenously administering an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof such that the subject is treated, wherein gastrointestinal adverse events associated with treatment are mild, wherein 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered intravenously followed by an oral administration, wherein it is administered intravenously for about 2–6 days, and wherein the total treatment period including intravenous and oral administration is about 8–12 days.
The independent claims collectively cover CSSSI treatment using compound 1 or a salt with a key safety characterization of mild gastrointestinal adverse events, either as an intravenous regimen limited to specified day counts or as an intravenous-to-oral step-down regimen with defined intravenous and total treatment periods.
Stated Advantages
GI adverse events associated with treatment are mild.
Documented Applications
Treating a human subject for complicated Skin and Skin Structure Infections (CSSSI) by administering 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline (compound 1) or a salt thereof.
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