Other β-lactamase Inhibitor (BLI) Combinations: Focus on VNRX-5133, WCK 5222 and ETX2514SUL

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1 Other β-lactamase Inhibitor (BLI) Combinations: Focus on VNRX-5133, WCK 5222 and ETX2514SUL David P. Nicolau, PharmD, FCCP, FIDSA Director, Center for Anti-Infective Research and Development Hartford Hospital Hartford, CT

2 Disclosures I am a consultant, speakers bureau member or have received research funding from: Achaogen, Bayer, Cepheid, Merck, Melinta, Pfizer, Shionogi, VenatoRx, Wockhardt Advisory Member: Clinical Laboratory Standards Institute (CLSI)

3 VNRX-5133 is a new-generation boronic acid β-lactamase inhibitor with a broad-spectrum encompassing both serine- and metallo- β- lactamases: Ambler Class A [ESBL and KPC] Class B [NDM and VIM] Class C [AmpC] Class D [OXA] VNRX-5133 The combination of VNRX-5133 with cefepime (FEP), a broad spectrum cephalosporin, has the potential to be a potent and attractive treatment option for infections caused by multi-drug resistant gram-negative bacteria, inclusive of carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa VNRX-5133

4 MICs and β-lactamase Expression of the Isolates Utilized in Murine Efficacy Studies MIC (mg/l) Isolate ID Bacterial Species FEP+VNRX-5133 β-lactamases Encoded FEP 4 mg/l EC 481 Escherichia coli > CTX-M-15 ECL 96 Enterobacter cloacae >512 8 TEM-OSBL, CTX-M-15, ACT-7 ECL 123 Enterobacter cloacae > TEM-OSBL, CTX-M-15, ACT-New Variant, OXA-48 ECL 124 Enterobacter cloacae >512 8 TEM-OSBL, CTX-M-15, ACT-7 KP 329B Klebsiella pneumoniae SHV-11, OXA-9, SHV-5, KPC-2, TEM-1 KP 510 Klebsiella pneumoniae CTX-M-11, SHV-11, DHA-1, TEM-1A KP 569 Klebsiella pneumoniae >512 4 OXA-48 & CTX-M-15 KP 575 Klebsiella pneumoniae >512 2 KPC KP 579 Klebsiella pneumoniae > SHV-11, TEM-1, CTX-M-15, OXA-48 KP 580 Klebsiella pneumoniae >512 8 SHV-OSBL, TEM-OSBL, CTX-M-15, OXA-48 KP 583 Klebsiella pneumoniae >512 4 SHV-32, TEM-1, CTX-M-15, OXA-48 KP 585 Klebsiella pneumoniae KPC KP 679 Klebsiella pneumoniae >512 4 OXA-232, OXA-9, TEM-1A, CTX-M-15, OXA-1 KP 686 Klebsiella pneumoniae >512 1 KPC-3, OXA-9, TEM-1A, SHV-11 KP 731 Klebsiella pneumoniae >512 1 SHV-11, TEM-1, KPC-3 KP 732 Klebsiella pneumoniae >512 1 SHV-OSBL, TEM-OSBL, KPC-2 KP 734 Klebsiella pneumoniae >512 2 KPC-3 KP 735 Klebsiella pneumoniae >512 2 KPC-2 KP 736 Klebsiella pneumoniae >512 1 SHV-11, CTX-M-55, OXA-48 KP 737 Klebsiella pneumoniae >512 2 SHV-OSBL, CTX-M-15, OXA-48 KP 738 Klebsiella pneumoniae >512 4 KPC-3 KP 739 Klebsiella pneumoniae >512 8 SHV-11, TEM-1, CTX-M-15, OXA-48 KP 740 Klebsiella pneumoniae >512 8 SHV-OSBL, TEM-OSBL, CTX-M-15, OXA-48 KP 742 Klebsiella pneumoniae >512 8 SHV-11, TEM-1, CTX-M-15, OXA-48 KP 743 Klebsiella pneumoniae >512 8 SHV-11, TEM-1, CTX-M-15, OXA-48 KP 744 Klebsiella pneumoniae >512 4 SHV-32, TEM-1, CTX-M-15, OXA-48 PSA 1593 Pseudomonas aeruginosa >512 4 KPC-2 PSA 1672 Pseudomonas aeruginosa >512 2 AmpC overexpression PSA 1679 Pseudomonas aeruginosa AmpC overexpression PSA 1681 Pseudomonas aeruginosa >512 8 AmpC overexpression Abdelraouf K, Almarzoky Abuhussain S, Nicolau DP. IDWeek2018, Abstract No. 1405, San Francisco, California 2018

5 Comparative Efficacy of Cefepime / VNRX-5133 Humanized Exposures (2/0.5g q8 2h inf) v. Cefepime Alone against Enterobacteriaceae & P. aeruginosa Expressing Various β-lactamases Abdelraouf K, Almarzoky Abuhussain S, Nicolau DP. IDWeek2018, Abstract No. 1405, San Francisco, California 2018

6 Cefepime Zidebactam (WCK 5222) Zidebactam (WCK5107) new Bicyclo-acyl Hydrazide (BCH) Pharmacophore FEP: Cefepime; ZID: Zidebactam; WCK 5222 is a combination of Cefepime (FEP) and Zidebactam (ZID) 2g + 1g IV q8h 1hr inf ZID is a non-β-lactam, dual acting βlactam Enhancer antibiotic FEP + ZID (WCK5222) have demonstrated synergy through complimentary target (PBPs) attainment Selective PBP activity of ZID (PBP2) and FEP (PBP3) across Gram-negatives FEP + ZID combination has proven efficacy against MDR pathogens (VIM, NDM, OXA) Enterobacteriaceae, P. aeruginosa and A. baumannii Livermore et al. JAC 2017 Moya et al. AAC 2017; Sader et al. JAC 2017 Sader et al. AAC 2017; Moya et al. IDWeek, New Orleans 2017

7 Neutropenic Murine Lung Model Cyclophosphamide 250 mg/kg (Day -4) Uranyl Nitrate 5 mg/kg (Day -3) Cyclophosphamide 100 mg/kg (Day -1) Cefepime %ft>mic MIC (µg/ml) Human Murine % % % 92.50% % 66.25% % 41.25% % 19.58% Intranasal Inoculation (Day 0) WCK5222 human simulated regimen* Bacterial burden determination Zidebactam %ft>mic MIC (µg/ml) Human Murine 24 hours % 92.50% % 70.00% % 41.25% % 20.42% % 3.75% *WCK5222 human simulated regimen results in murine plasma concentrations that correlate with human exposures (in terms of %ft>mic) following 1-hour IV infusions of: cefepime 2 g q8h and zidebactam 1 g q8h Avery LM, Abdelraouf K, Nicolau DP Antimicrob Agents Chemother 62:e doi: /aac

8 In Vitro Potency of Cefepime Zidebactam (WCK 5222) against A. baumannii A. baumannii β-lactamases Encoded Broth Microdilution MIC (µg/ml) Meropenem Zidebactam Cefepime WCK TEM-1D, ADC-25, OXA-66 2 > PER-7, OXA-23, OXA-203 >8 > ADC-25, OXA-23, OXA-82 >8 > OXA-24, OXA-65, TEM-1B >8 > ADC-25, OXA-23, OXA-223 >8 > JJ 5-13 ADC-33, OXA-23, OXA-82 >64 > JJ 12-1 ADC-81-like, OXA-23, OXA-69 >64 > JJ 3-20 ADC-81-like, OXA-24, OXA-65, TEM-1 >64 > OXA-24, OXA-65, TEM-1B >8 >512 > JJ ADC-96-like, CARB-16, OXA-10, OXA-23-like, OXA-58, OXA-68, OXA >512 > ADC-25, OXA-23, OXA-66 >8 > JJ 4-25 ADC-30, OXA-66, OXA-72 >64 > JJ 1-1 ADC-81-like, OXA-24, OXA-65, TEM-1 >64 >512 > Avery LM, Abdelraouf K, Nicolau DP Antimicrob Agents Chemother 62:e doi: /aac

9 Remarkable Potency Observed Among All 13 A. baumannii Isolates Bacterial growth was observed in the lungs of animals treated with saline, cefepime, and zidebactam alone WCK5222 (cefepimezidebactam) achieved >2 log 10 kill across all isolates, including isolates with MIC = 64 mg/l As zidebactam does NOT inhibit OXA enzymes that degrade cefepime, these data support the β-lactam enhancer action of zidebactam Avery LM, Abdelraouf K, Nicolau DP Antimicrob Agents Chemother 62:e doi: /aac

10 ETX2514SUL is a Novel Bactericidal β-lactam/β-lactamase Inhibitor Combination Under Development for Intravenous Treatment of Acinetobacter infections Sulbactam Activity as a β-lactamase inhibitor Also a β-lactam with intrinsic activity against A. baumannii Extensively use to treat A. baumannii β-lactamase-mediated resistance now common with MIC 90 >32 mg/l ETX2514 Novel β-lactamase inhibitor Potent broad-spectrum inhibitor of Class D β- lactamases Also potent broadspectrum inhibitor of Class A and C β- lactamases

11 In vitro activity against Acinetobacter baumannii Activity unchanged in carbapenem-resistant, colistin-resistant and multidrug resistant strains Cumulative % MIC Distribution for globally diverse A. baumannii 0 MIC of sulbactam in the presence of ETX2514 (mg/l) (1) 2011 N = N = N = N =1, (2) N = N = N = 825 All N = > Combined with 4 mg/l of ETX study performed at JMI; other years performed at IHMA.

12 ETX2514SUL PK/PD Key PK drivers identified by PK/PD evaluations in vitro and in vivo Exposure targets for sulbactam and for ETX2514 established Sulbactam: 50% Time>MIC ETX2514: AUC 0-24h /MIC = 10 Dosing regimen for Phase 2/3 Sulbactam 1 g plus ETX g 3-hour infusion Dosed every 6 hours Probability of target attainment for MIC 4 mg/l is 99% Relationship between ETX02514 AUC 0-24h/τ in the in vitro chemostat model 1 1 A. baumannii ARC5081 (OXA-23; OXA-94): MIC (sulbactam) = 16 mg/l, MIC (sulbactam/etx2514) = 2.9 mg/l.

13 ETX2514SUL Generally Safe & Well Tolerated in 3 Phase 1 and a Phase 2 Clinical study 139 healthy subjects and 79 patients have received 1 dose of ETX2514 No dose-related systemic adverse events Up to 8 g single dose or 2 g q6h Sulbactam 1 g plus ETX g with imipenem/cilastatin 0.5 g Generally well tolerated ETX2514 demonstrated well behaved PK Dose proportional exposure up to 8 g No drug-drug interaction (2-way) with sulbactam and/or imipenem/cilastatin Good pulmonary exposure in healthy subjects PK in patients with renal impairment pending ETX2514 Concentration (μg/ml) Mean ETX2514 Concentration in Plasma and Epithelial Lining Fluid (ELF) (n=30) Time (hours) Infusion period Plasma ELF ETX2514 ELF AUC 0-6h 40.1 µg h/ml 1 Phase 1 study in 30 healthy subjects receiving sulbactam 1 g and ETX2514 1g infused over 3 hrs q6h

14 NEW BL BLI Combinations Enhance potency against Carbapenemase- Producing Enterics & PSA Cefepime - VNRX-5113 [KPC, OXA, MBL] Cefepime - Zidebactam [KPC, OXA, MBL] Acinetobacter baumannii Cefepime Zidebactam» Complimentary target (PBP) attainment β-lactam Enhancer Sulbactam - ETX2514 (ETX2514SUL)» Focus activity for Acinetobacter baumannii

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