Claims for Patent: 10,111,890

Summary for Patent: 10,111,890

Title:	9-aminomethyl minocycline compounds and uses thereof
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 the 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days.
Inventor(s):	Tanaka; S. Ken (Bellevue, WA), Tzanis; Evangelos L. (Newtown Square, PA), Garrity-Ryan; Lynne (Melrose, MA), Manley; Amy L. (Phoenixville, PA)
Assignee:	Paratek Pharmaceuticals, Inc. (Boston, MA)
Application Number:	15/667,683
Patent Claims:	1. A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally 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 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days. 2. The method of claim 1, wherein the bacterial skin or skin structure infection is wound infection, cellulitis/erysipelas, major abscess, furuncles/boils, carbuncle, Staphylococcal scalded skin syndrome (SSSS), or ecthyma. 3. The method of claim 1, wherein the bacterial skin or skin structure infection is Acute Bacterial Skin and Skin Structure Infection (ABSSSI). 4. The method of claim 3, wherein the ABSSSI is community-acquired ABSSSI. 5. The method of claim 4, wherein the ABSSSI comprises wound infection, cellulitis/erysipelas, and/or major abscess. 6. The method of claim 1, wherein said bacterial skin or skin structure infection is a result of skin injury including but not limited to trauma, a surgical procedure, or IV drug use. 7. The method of claim 1, wherein said human subject is administered 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline under fasting condition. 8. The method of claim 1, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered once per day. 9. The method of claim 1, wherein said subject is treated up to and including about 14 days, up to and including about 10 days, up to and including about 9 days, up to and including about 8 days, or up to and including about 7 days, up to and including about 5 days, such that said subject is treated. 10. The method of claim 9, wherein said subject is treated for 7-10 days. 11. The method of claim 1, wherein said salt is a tosylate salt. 12. The method of claim 1, wherein said bacterial skin or skin structure infection is known or suspected to be caused by Gram-positive pathogens selected from the group consisting of: Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus species, Streptococcus agalactiae, Streptococcus mitis, Enterococcus species (Enterococcus faecalis (such as VRE or VSE), or Enterococcus faecium (such as VRE or VSE)), Streptococcus anginosus group (S. anginosus, S. constellatus, and S. intermedius, that is beta-, alpha- or non-hemolytic), Viridans group Streptococci (VGS), Clostridium perfringens, Finegoldia magna, and a combination thereof. 13. The method of claim 12, wherein: (a) said Staphylococcus aureus is methicillin-resistant Staphylococcus aureus (MRSA), or methicillin-susceptible Staphylococcus aureus (MSSA); (b) said Streptococcus species include Streptococcus anginosus group; (c) said Streptococcus species include beta-hemolytic Streptococci or S. anginosus; (d) said Streptococcus species include non-hemolytic Streptococci or S. intermedius; (e) said Streptococcus species include alpha-hemolytic Streptococci or S. constellatus; (f) said Enterococcus species include Enterococcus faecalis (VSE); or, (g) said Streptococcus species include Streptococcus pyogenes. 14. The method of claim 1, wherein said bacterial skin or skin structure infection is known or suspected to be caused by Gram-negative pathogens selected from the group consisting of: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Prevotella denticola, Prevotella melaninogenica, and a combination thereof. 15. The method of claim 1, wherein GI adverse events (AEs) associated with treatment are predominantly mild, or do not result in discontinuation of therapy. 16. The method of claim 1, wherein Area Under the Curve from 0-24 hours (AUC.sub.0-24) after the first two doses of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof is about 10,000 ng*h/mL. 17. The method of claim 1, wherein each dose of said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or salt thereof is administered as 150 mg tablets.