Claims for Patent: 11,541,064

Summary for Patent: 11,541,064

Title:	Methods of identifying dosing regimens
Abstract:	Methods for identification of new dosing strategies which optimize positive treatment outcomes and patient safety. Specifically, new dosing strategies for fosfomycin and pharmaceutically acceptable salt thereof which have improved treatment outcomes in mammals. For example, a method of treating mammals having a bacterial infection with fosfomycin or a pharmaceutically acceptable salt thereof using improved dosing regimens.
Inventor(s):	Evelyn Ellis-Grosse
Assignee:	Meitheal Pharmaceuticals Inc
Application Number:	US16/618,037
Patent Claims:	1. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein said renally impaired patient has an estimated creatinine clearance of >40 to ≤50 mL/min comprising administering 4 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours. 2. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein said renally impaired patient has an estimated creatinine clearance of >30 to ≤40 mL/min comprising administering 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously once, then with 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours. 3. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein said renally impaired patient has an estimated creatinine clearance of >20 to ≤30 mL/min comprising administering a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously and a second dose of 5 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 24 hours. 4. The method of claim 1, 2, or 3, wherein the duration of treatment is between about 7 days and about 14 days. 5. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein said renally impaired patient has an estimated creatinine clearance of >40 to ≤50 mL/min or of >30 to ≤40 mL/min comprising administering 4 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours if said renally impaired patent has an estimated creatinine clearance of >40 to ≤50 mL/min or administering 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously once, then with 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours if said renally impaired patient has an estimated creatinine clearance of >30 to ≤40 mL/min. 6. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein said renally impaired patient has an estimated creatinine clearance of >40 to ≤50 mL/min or of >30 to ≤40 mL/min or of >20 to ≤30 mL/min comprising administering 4 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours if said renally impaired patent has an estimated creatinine clearance of >40 to ≤50 mL/min or administering 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously once, then with 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours if said renally impaired patient has an estimated creatinine clearance of >30 to ≤40 mL/min or administering 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously once, then with 5 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 24 hours if said renally impaired patient has an estimated creatinine clearance of >20 to ≤30 mL/min. 7. The method of claim 5 or 6, wherein the duration of treatment is between about 7 days and about 14 days. 8. A dosing regimen for administering fosfomycin or a pharmaceutically acceptable salt thereof to a renally impaired patient in need of treatment wherein the renally impaired patient is diagnosed with a cUTI and has an estimated creatinine clearance of >10 to 20 mL/min, the dosing regimen comprising administering to the patent 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously once, followed by a second administration of 5 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 24 hours. 9. The method of claim 8, wherein the duration of treatment is between about 7 days and about 14 days.