IP Library Granted Patent US 12,702,676
Granted Patent B2
US 12,702,676 · App. 18/092,781 · Granted Aug 11, 2026

Fosfomycin dosing regimens

Inventor: Evelyn Ellis-Grosse (Marietta, GA)
Assignee: Meitheal Pharmaceuticals, Inc.
A61K31/665A61K9/0019A61P31/04
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,702,676
App. No.
18/092,781
Filed
Jan 3, 2023
Granted
Aug 11, 2026
Kind
B2
Art Unit
1625
USPC
514/100
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.

Claims (10)

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 between 41-50 mL/min comprising administering a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof followed by a second dose of 4 grams intravenously every 8 hours.

2 . The dosing regimen of claim 1 , wherein the duration of treatment is up to about 14 days.

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 between 31-40 mL/min comprising administering a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously and a second dose of 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours.

4 . The dosing regimen of claim 3 , wherein the duration of treatment is up to 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 between 21-30 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.

6 . The dosing regimen of claim 5 , wherein the duration of treatment is up to about 14 days.

7 . 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 between 11-20 mL/min, the dosing regimen comprising administering to the patent a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously, followed by a second administration of 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 24 hours.

8 . The dosing regimen of claim 7 , wherein the duration of treatment is up to about 14 days.

9 . 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 selected from the group consisting of 41-50 mL/min, 31-40 mL/min, 21-30 mL/min and 11-20 mL/min, wherein the dosing regimen comprises administering a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof followed by a second dose of 4 grams intravenously every 8 hours for the patient having the estimated creatinine clearance of 41-50 mL/min, a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously and a second dose of 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 8 hours for the patient having the estimated creatinine clearance of 31-40 mL/min, 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 for the patient having the estimated creatinine clearance of 21-30 mL/min and a first dose of 6 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously and a second dose of 3 grams of fosfomycin or a pharmaceutically acceptable salt thereof intravenously every 24 hours for the patient having the estimated creatinine clearance of 11-20 mL/min.

10 . The dosing regimen of claim 9 , wherein the duration of treatment is up to about 14 days.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2024
From: ZAVANTE THERAPEUTICS, INC.
To: MEITHEAL PHARMACEUTICALS, INC.
Reel/Frame 068664/0352 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: ELLIS-GROSSE, EVELYN J.
To: ZAVANTE THERAPEUTICS, INC.
Reel/Frame 067451/0860 →
Continuity (5)
Continuation In Part 16618037 · May 30, 2018
Provisional Application 62582880 · Nov 7, 2017
Provisional Application 62567599 · Oct 3, 2017
Provisional Application 62512655 · May 30, 2017
Related Publication 20230248750A1 · Aug 10, 2023
References Cited (15)
US 4950465A · Sato et al. · 1990 [cited by applicant]
US 11541064B2 · Ellis-Grosse · 2023 [cited by examiner]
US 20100063005A1 · Fiala · 2010 [cited by applicant]
US 20150132382A1 · Dedhiya et al. · 2015 [cited by applicant]
US 20160346354A1 · Heslet et al. · 2016 [cited by applicant]
JP 5750919 · 1982 [cited by applicant]
Ansel, Howard C., et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” New Drug Development and Approval Process. 7th edition. (1999), pp. 48-53. (Year: 1999). [cited by examiner]
Pruekprasert et al., “In vitro activity of fosfomycin-gentamicin, fosfomycin-ceftazidime, fosfomycin-imipenem and ceftazidime-gentamicin combinations against ceftazidime-resistant pseudomonas aeruginosa.” (Sep. 2005) So… [cited by applicant]
Okazaki et al., “Effectiveness of fosfomycin combined with other antimicrobial agents against multidrug-resistant Pseudomonas aeruginosa isolates using the efficacy time index assay.” (2002) J Infect Chemother 8:37-42, … [cited by applicant]
Kastoris et al., “Synergy of fosfomycin with other antibiotics for Gram-positive and Gram-negative bacteria.” (2010) Eur J Clin Pharmacol 66:359-368, p. 366, Table 3. [cited by applicant]
Wikipedia, “Nephrotoxicity”, Jan. 7, 2017 (Jan. 7, 2017), retrieved on Sep. 14, 2018 from https://en.wikipedia.org/w/index.php?title=Nephrotoxicity&oldid=758775998; entire document, especially p. 2 para 7. [cited by applicant]
Nagel et al., “Clinical efficacy of fosfomycin for the treatment of complicated lower tract and uncomplicated urinary tract infections,” vol. 8 No. 151 doi: 10.3823/1750, (2015); entire document, especially abstract. [cited by applicant]
Patel et al. “Determination of antibiotic dosage adjustments in patients with renal impairment: elements of success.” (2010) J. Antimicrob Chemother 65:2285-2290. [cited by applicant]
Clinical Trials: “NCT02753946: Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam Treatment of cUTI/AP Infections (ZEUS)” URL: <https://classic.clinicaltrials.gov/ct2/history/NCT02753946?V_8=View#S… [cited by applicant]
Lima et al., In Vitro Activity of Antimicrobial Combinations Against Multidrug-resistant Pseudomonas aeruginosa. (2013) Rev Soc Braz Med Trop 46(3):299-303, May-Jun. [cited by applicant]