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Susceptibility of Gram-Positive Clinical Isolates from Hospitals in the USA 2021-A-5473- from 2019 to Eravacycline and Comparators MICROBE 1* 1 1 1 2 *Contact: Stephen Hawser Contact: Tetraphase Pharmaceuticals Medical Information S. Hawser , I. Morrissey , N. Kothari , F. Monti , S. Carlisle [email protected] [email protected] +41244737510 1-833-793-7282 1, IHMA Europe, Rte. De I’Ile-au-Bois 1A, 1870 Monthey, Switzerland; 2, Tetraphase Pharmaceuticals (A wholly owned subsidiary of La Jolla Pharmaceuticals), Waltham, MA, USA www.ihma.com

Introduction Results Conclusion Figure 1. Distribution of All Isolates (n =562) by Region / Frequency Table 2. Susceptibility of E. faecalis (n=179) to Eravacycline and Table 5. Susceptibility of MSSA (n=91) to Eravacycline and Comparators Eravacycline is a fully- Comparators Eravacycline exhibited good activity against the 250 234 synthetic, fluorocycline Drug %S* MIC50 MIC90 MIN MIC MAX MIC majority of isolates tested though there was one Drug %S* MIC50 MIC90 MIN MIC MAX MIC Amoxicillin Clavulanate NB** 0.5 1 ≤0.06 > 1 antibacterial approved by the Amoxicillin Clavulanate NB** 0.5 1 0.25 1 s 200 notable difference in susceptibility to eravacycline

e 78.0 1 > 4 0.5 > 4 t

a Ampicillin 100.0 1 1 ≤0.25 2 FDA and EMA for the l Ceftaroline 100.0 0.12 0.25 ≤0.06 0.5 based on the use of FDA or EUCAST o s

i 150 Daptomycin 100.0 1 2 0.12 2 91.2 0.12 0.25 0.06 > 2 treatment of complicated f

o breakpoints. For example, 87.4% and 99% of

r Eravacycline (EUCAST) 99.4 0.06 0.06 0.008 0.25 Daptomycin 100.0 0.5 0.5 0.25 0.5 e 100

intra-abdominal infections b 75 Eravacycline (FDA) 99.4 0.06 0.06 0.008 0.25 Eravacycline (EUCAST) 100.0 0.03 0.06 0.015 0.25 MRSA isolates were eravacycline-susceptible m 63 (cIAI) in patients 18 years of u 44 Eravacycline (FDA) 96.7 0.03 0.06 0.015 0.25 N 50 31 28 83.2 1 > 8 0.25 > 8 based on FDA and EUCAST breakpoints, age & older. The purpose of 26 22 21 18 Levofloxacin 91.2 0.25 0.5 0.06 > 4 99.4 2 2 0.25 4 Linezolid 100.0 1 2 ≤0.5 2 respectively. Overall, irrespective of breakpoints 0 this study was to further 26.8 8 > 8 0.06 > 8 Minocycline 98.9 ≤0.06 0.12 ≤0.06 8 used, susceptibility of species/phenotypes to monitor the in vitro activity of Penicillin 100.0 2 4 0.25 8 Oxacillin 100.0 0.5 0.5 ≤0.06 1 Penicillin 31.9 1 > 2 ≤0.12 > 2 21.8 32 > 32 0.12 > 32 eravacycline were consistently greater than 95%. eravacycline against Gram- Tetracycline 96.7 0.25 0.25 ≤0.06 > 16 Region E, Illinois, Indiana, Michigan, Wisconsin, Ohio; Region C, Florida, Georgia; Region A, New York; Region I, California; Region (FDA) 92.2 0.12 0.25 0.015 2 Overall, eravacycline was the most active positive pathogens from USA H, Colorado; Region B, New Jersey; Region G, Nebraska; Region F, New Mexico; Region J, Washington; Region D, Kentucky Tigecycline (FDA) 100.0 0.12 0.25 0.03 0.25 Vancomycin 97.8 1 2 0.5 > 16 Vancomycin 100.0 1 1 0.5 2 by MIC90. Further surveillance hospitals during 2019, Figure 2. Number and Percent of Isolates by Infection Source *, %S, percent susceptible; **NB, no defined breakpoint *, %S, percent susceptible; **NB, no defined breakpoint including Staphylococcus monitoring is ongoing and breakpoint Body fluids 66; aureus (including methicillin- Table 3. Susceptibility of E. faecium (n=169) to Eravacycline and Table 6. Susceptibility of MRSA (n=103) to Eravacycline and Comparators harmonization including availability of Gastro-intestinal 115; Genito-urinary 233; 11.7% Comparators eravacycline. CLSI breakpoints and updated resistant S. aureus, MRSA), 20.5% 41.5% Drug %S* MIC50 MIC90 MIN MIC MAX MIC FDA breakpoints would be beneficial when Enterococcus spp. (including Drug %S* MIC50 MIC90 MIN MIC MAX MIC Amoxicillin Clavulanate NB** > 1 > 1 ≤0.12 > 1 Amoxicillin Clavulanate NB** > 1 > 1 > 1 > 1 vancomycin-resistant Azithromycin 13.6 > 4 > 4 0.5 > 4 comparing the susceptibility to eravacycline and Ampicillin 20.7 > 8 > 8 ≤0.25 > 8 Enterococcus, VRE) and Ceftaroline 93.2 1 1 0.25 2 tigecycline. Daptomycin 99.4 2 4 0.25 8 Clindamycin 68.0 0.12 > 2 0.06 > 2 Streptococcus spp. Eravacycline (EUCAST) 98.2 0.03 0.06 0.015 0.5 Daptomycin 100.0 0.5 0.5 0.12 1 Eravacycline (FDA) 95.3 0.03 0.06 0.015 0.5 Eravacycline (EUCAST) 99.0 0.03 0.12 0.015 0.5 References Levofloxacin 18.3 > 8 > 8 0.25 > 8 Eravacycline (FDA) 87.4 0.03 0.12 0.015 0.5 Materials & Methods Levofloxacin 18.5 4 > 4 0.12 > 4 Linezolid 98.8 1 2 0.5 4 1. CLSI, 2018. Methods for Dilution Antimicrobial Linezolid 100.0 1 2 ≤0.5 2 Minocycline 58.0 4 > 8 0.06 > 8 Susceptibility Tests for Bacteria That Grow Isolates were collected Minocycline 98.1 ≤0.06 0.25 ≤0.06 > 8 Penicillin 18.9 > 8 > 8 0.12 > 8 Oxacillin 0.0 > 2 > 2 > 2 > 2 Aerobically; Approved Standard - Tenth Edition during 2019 from various Tetracycline 33.7 32 > 32 0.12 > 32 Penicillin 0.0 > 2 > 2 > 2 > 2 M07-A10. Clinical and Laboratory Standards body sites and from different Tigecycline (FDA) 79.3 0.12 2 0.03 2 Tetracycline 93.2 0.25 1 0.12 > 16 Respiratory 148; Tigecycline (FDA) 100.0 0.12 0.25 ≤0.015 0.5 Institute (CLSI), Wayne, PA 19087-1898 USA Vancomycin 37.3 > 16 > 16 0.5 > 16 regions within the United 26.3% Vancomycin 100.0 1 1 0.5 2 *, %S, percent susceptible; **NB, no defined breakpoint States (classified by CDC *, %S, percent susceptible; **NB, no defined breakpoint 2. Clinical and Laboratory Standards Institute. region). Minimum inhibitory Table 4. Susceptibility of Vancomycin-Resistant Enterococci (VRE, n=110) Table 7. Susceptibility of S. anginosus group (n=20) to Eravacycline and Performance Standards for Antimicrobial concentrations (MICs) were Table 1. Susceptibility of Enterococcus spp. (n=348) to Eravacycline and to Eravacycline and Comparators Comparators Susceptibility Testing – 31st ed. CLSI Supplement determined by CLSI broth Comparators M100. 2021. CLSI, Wayne, PA. Drug %S* MIC50 MIC90 MIN MIC MAX MIC Drug %S* MIC50 MIC90 MIN MIC MAX MIC microdilution. Antibiotic Amoxicillin Clavulanate NB** > 1 > 1 0.5 > 1 Drug %S* MIC50 MIC90 MIN MIC MAX MIC Azithromycin 80.0 0.06 > 1 ≤0.03 > 1 susceptibility was determined Amoxicillin Clavulanate NB** 1 > 1 ≤ 0.12 > 1 Ampicillin 3.6 > 8 > 8 1 > 8 Ceftaroline NB** 0.015 0.03 ≤0.004 0.25 3. The European Committee on Antimicrobial Ceftriaxone 95.0 0.06 0.25 ≤0.015 > 2 using the most updated FDA Ampicillin 61.5 1 > 8 ≤ 0.25 > 8 Daptomycin 99.1 2 2 0.5 8 Susceptibility testing, 2021. Breakpoint tables for Eravacycline (EUCAST) 98.2 0.03 0.06 0.015 0.5 Clindamycin 90.0 0.03 0.06 ≤0.015 > 1 Daptomycin 99.7 2 2 0.12 8 Daptomycin 100.0 0.12 1 ≤0.03 1 interpretation of MICs and zone diameters. Version and EUCAST breakpoints for Eravacycline (FDA) 94.6 0.03 0.06 0.015 0.5 Eravacycline (EUCAST) 99.1 0.03 0.06 0.008 0.5 Eravacycline (EUCAST) 100.0 0.004 0.03 ≤0.001 0.03 11.0 http://www.eucast.org eravacycline, FDA Eravacycline (FDA) 97.4 0.03 0.06 0.008 0.5 Levofloxacin 0.0 > 8 > 8 8 > 8 Eravacycline (FDA) 100.0 0.004 0.03 ≤0.001 0.03 Linezolid 99.1 1 2 0.5 4 breakpoints for tigecycline Levofloxacin 51.7 2 > 8 0.25 > 8 Levofloxacin 95.0 ≤0.25 1 ≤0.25 4 Minocycline 48.2 8 > 8 0.06 > 8 Linezolid 100.0 0.5 1 ≤0.12 2 Acknowledgments and CLSI breakpoints for Linezolid 99.1 1 2 0.25 4 Penicillin 3.6 > 8 > 8 4 > 8 95.0 ≤0.03 0.06 ≤0.03 > 0.5 Minocycline 42.0 8 > 8 0.06 > 8 Minocycline NB** ≤0.06 2 ≤0.06 8 other . Currently Tetracycline 13.6 32 > 32 0.12 > 32 This study was funded by a grant from Tetraphase Penicillin 60.6 4 > 8 0.12 > 8 Penicillin 95.0 ≤0.12 ≤0.12 ≤0.12 > 2 there are no CLSI Tigecycline (FDA) 85.5 0.12 2 0.06 2 Pharmaceuticals (A wholly owned subsidiary of La Jolla Tetracycline 27.6 32 > 32 0.12 > 32 Tetracycline 75.0 0.25 > 4 ≤0.03 > 4 Vancomycin 0.0 > 16 > 16 > 16 > 16 Tigecycline (FDA) 100.0 0.015 0.06 ≤0.008 0.06 Pharmaceuticals). breakpoints for both Tigecycline (FDA) 85.9 0.12 2 0.015 2 *, %S, percent susceptible; **NB, no defined breakpoint Vancomycin 100.0 0.5 1 ≤0.06 1 Vancomycin 68.4 1 > 16 0.5 > 16 eravacycline and tigecycline. *, %S, percent susceptible; **NB, no defined breakpoint *, %S, percent susceptible ; **NB, no defined breakpoint