<<

Mode of action of , a novel , active against highly resistant Gram-negative including -resistant strains of and non-fermenting bacteria

Yoshinori Yamano, Masakatsu Tsuji, Meredith Hackel, Daniel Sahm, Roger Echols

1 Disclosures

Shionogi & Co., Ltd IHMA Medical Consultant

Yoshinori Yamano Meredith Hackel Roger Echols Masakatsu Tsuji Daniel Sahm

2 Features of Cefiderocol

• A first-in-class siderophore cephalosporin • Broad coverage against Gram-negative bacteria including CRE and MDR non-fermenters. No activity for Gram-positive or anaerobes. • Best correlation between in vivo efficacy and MIC determined in - depleted medium • Cefiderocol demonstrated non-inferiority over treatment with / in cUTI study. Results consistent with superiority (Oral late breaker session) • Good safety and tolerability in clinical studies

3 Potent activity of Cefiderocol against Carbapenem-Resistant Isolates

MIC Distribution of 1,873 Carbapenem-resistant Gram-Negative Poster #1316 Clinical Isolates From Global Surveillance Study

Enterobacteriaceae (1022) baumannii (368) (262)

Stenotrophomonas maltophilia (217) Percentage (%) Percentage

MIC (mg/L) 96.2% of all isolates susceptible to cefiderocol at  4 mg/L 4 Activity of Cefiderocol against Carbapenem-Resistant Enterobacteriaceae

Comparison of MIC Distribution with other comparators Poster #1316 Percentage (%) Percentage

MIC (mg/L)

5 Activity of Cefiderocol against MDR P. aeruginosa

Comparison of MIC Distribution with other comparators Poster #1316 Percentage (%) Percentage

MIC (mg/L)

6 Activity of Cefiderocol against MDR A. baumannii

Comparison of MIC Distribution with other comparators Poster #1316 Percentage (%) Percentage

MIC (mg/L)

7 Activity of Cefiderocol against S. maltophilia

Comparison of MIC Distribution with other comparators Poster #1316 Percentage (%) Percentage

MIC (mg/L)

8 Two Important Mode of Action of Cefiderocol

• High stability to carbapenemases • Stable to both serine-type (KPC, OXA etc) and metallo- type carbapenemases (VIM, IMP, NDM, L1 etc) • Efficient penetration through the outer membrane via active iron transporters • Strong chelating ability to Fe3+ as well as • Utilization of multiple iron transporters of multiple bacterial species of Gram-negative bacteria

9 Stability of Cefiderocol to Carbapenemases

Cefiderocol

Cefepime

Ceftazidime

Meropenem

10 Chelating ability of Cefiderocol with Ferric Iron

Cefiderocol Catechol 3-methoxy cefiderocol

0.035mM Fe3+ OD OD 0mM Fe3+

Wavelength (nm) Wavelength (nm)

• Only cefiderocol showed the different absorption spectrum by the addition of iron, indicating the formation of chelating complex with iron • Log K (stability constant) of cefiderocol-iron chelating complex was calculated to be 4.1 at pH 7 • Pyoverdine, a siderophore produced by P. aeruginosa, has logK of 3.9 to form chelating complex with iron at pH 7 11 Calcein Assay to Evaluate Iron Concentration in Bacterial Cells

: Siderophore Calcein-AM (nonfluorescent)

Fe Fe Fe Fe : Siderophore-iron

Fe

Fe Fe Fe Esterase Fe Fe Fe Add Siderophore

IROMP IROMP Fluorescence of calcein is (Iron regulated OMP) Iron is transported quenched by the iron : Calcein (fluorescent) by sideropohore

12 Uptake of Cefiderocol into Bacterial Cells with Iron

Enhancement of iron uptake into P. aeruginosa cells by cefiderocol

Cefiderocol

Pyoverdine

Catechol 3-methoxy cefiderocol

Control

Iron in the bacterial cells significantly increased by the addition of cefiderocol or pyoverdine, suggesting that iron uptake into bacterial cells was enhanced in the presence of cefiderocol and pyoverdine

13 Uptake of Cefiderocol into Bacterial Cells under Iron-Depleted Conditions

Enhancement of cefiderocol uptake into P. aeruginosa cells under iron-depleted conditions

iron-depleted conditions

iron-sufficient conditions

Cefiderocol uptake into bacterial cells was enhanced when grown under iron-depleted conditions

14 Conclusion • Cefiderocol was shown to penetrate efficiently through the outer membrane via active iron transporters • Formation of chelating complex with iron as well as pyoverdine • Increase of iron uptake into the bacterial cells in the presence of cefiderocol as well as pyoverdine • Enhancement of cefiderocol uptake into bacterial cells under the iron-deficient conditions, which induce the production of iron transporters

• Cefiderocol exhibited highly potent in vitro antibacterial activity against carbapenem resistant Gram-negative bacteria due to the following reasons • Utilization of active iron transporters • High stability to both serine- and metallo-type carbapenemases

• Cefiderocol is a promising candidate for the treatment of serious infections caused by Gram-negative bacteria including CR strains • Broad Gram-negative activity including non-fermenters P. aeruginosa, A. baumannii and Stenotrophomonas maltophilia

15 End of File