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Antibiotics Currently in Clinical Development

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Antibiotics Currently in Clinical Development A data table from Feb 2018 Antibiotics Currently in Global Clinical Development Note: This data visualization was updated in December 2017 with new data. As of September 2017, approximately 48 new antibiotics1 with the potential to treat serious bacterial infections are in clinical development. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be approved for patients.* Below is a snapshot of the current antibiotic pipeline, based on publicly available information and informed by external experts. It will be updated periodically, as products advance or are known to drop out of development. Because this list is updated periodically, endnote numbers may not be sequential. In September 2017, the antibiotics pipeline was expanded to include products in development globally. Please contact [email protected] with additions or updates. Expected activity Expected activity against CDC Development against resistant Drug name Company Drug class Target urgent or WHO Potential indication(s)?5 phase2 Gram-negative critical threat ESKAPE pathogens?3 pathogen?4 Approved for: Acute bacterial skin and skin structure infections; other potential Baxdela Approved June 19, Melinta Bacterial type II Fluoroquinolone Possibly No indications: community-acquired bacterial (delafloxacin) 2017 (U.S. FDA) Therapeutics Inc. topoisomerase pneumonia and complicated urinary tract infections6 Approved for: Complicated urinary Rempex tract infections including pyelonephritis; Vabomere Pharmaceuticals β-lactam (carbapenem) other potential indications: complicated Approved Aug. 30, (Meropenem + Inc. (wholly owned + β-lactamase inhibitor PBP; β-lactamase Yes Yes (CRE) intra-abdominal infections, hospital- 2017 (U.S. FDA) Vaborbactam) subsidiary of The (cyclic boronate)11,13 acquired bacterial pneumonia/ Medicines Co.) ventilator-associated bacterial pneumonia New drug Complicated urinary tract infections application including acute pyelonephritis, hospital- submitted for 30S subunit of acquired bacterial pneumonia/ Plazomicin complicated Achaogen Inc. Aminoglycoside Yes Yes (CRE) bacterial ribosome ventilator-associated bacterial urinary tract pneumonia, complicated infections intra-abdominal infections (U.S. FDA) Possibly AIC4999 Phase 16 AiCuris β-lactam PBP Possibly Bacterial infections (CRE, CRPA, CRAB) Continued on the next page Expected activity Expected activity against CDC Development against resistant Drug name Company Drug class Target urgent or WHO Potential indication(s)?5 phase2 Gram-negative critical threat ESKAPE pathogens?3 pathogen?4 β-lactam Complicated urinary tract infections,6 Cefepime + (cephalosporin) + Yes (CRE); possibly and hospital-acquired bacterial Zidebactam Phase 1 Wockhardt Ltd. PBP; β-lactamase Yes β-lactamase inhibitor (CRPA) pneumonia/ventilator-associated (WCK 5222) (diazabicyclooctane) bacterial pneumonia6 Methionyl-tRNA CRS3123 Phase 1 Crestone Inc. Diaryldiamine11 No Yes (C. difficile) C. difficile infections synthetase12 Delpazolid15 LegoChem 50S subunit of Phase 1 Oxazolidinone No No Bacterial infections (LCB01-0371) Biosciences Inc. bacterial ribosome Bacterial type II DS-2969 Phase 16 Daiichi Sankyo Unknown topoisomerase No Yes (C. difficile) Bacterial enteritis (GyrB) β-lactam (sulbactam) Entasis Bacterial infections ETX2514SUL Phase 1 + β-lactamase inhibitor PBP; β-lactamase Yes Yes (CRAB) Therapeutics Inc. (caused by A. baumannii)6 (diazabicyclooctane) GlaxoSmithKline Siderophore-β-lactam GSK3342830 Phase 1 PLC (Shionogi PBP Yes Yes (CRE, CRAB, CRPA) Bacterial infections (cephalosporin) licensee) KBP BioSciences 30S subunit of Community-acquired bacterial KBP-7072 Phase 1 Pharmaceutical Tetracycline Possibly No bacterial ribosome pneumonia6 Technical Co. Ltd. 50S subunit of bacterial Oxazolidinone- MCB3837 Phase 16 Morphochem Ag. ribosome; No Yes (C. difficile) C. difficile infections6 quinolone hybrid bacterial type II topoisomerase MGB Biopharma DNA minor groove MGB-BP-3 Phase 1 Distamycin11 No Yes (C. difficile) C. difficile-associated diarrhea Ltd. binder12 Meiji Seika Pharma Co. Nacubactam Ltd./Fedora β-lactamase inhibitor Yes (CRE); (OP0595/ Phase 1 β-lactamase, PBP2 Yes Bacterial infections Pharmaceuticals (diazabicyclooctane) possibly (CRPA) RG6080) Inc. (Roche licensee) Spero Possibly SPR74114 Phase 1 Polymyxin Cell membrane12 Possibly Bacterial infections Therapeutics Inc. (CRE, CRPA, CRAB) Continued on the next page Expected activity Expected activity against CDC Development against resistant Drug name Company Drug class Target urgent or WHO Potential indication(s)?5 phase2 Gram-negative critical threat ESKAPE pathogens?3 pathogen?4 Community-acquired bacterial Spero SPR9947 Phase 16 β-lactam (carbapenem) PBP Yes No pneumonia6 and complicated urinary Therapeutics Inc. tract infections6 Tetraphase 30S subunit of Community-acquired bacterial TP-271 Phase 1 Pharmaceuticals Tetracycline No No bacterial ribosome pneumonia Inc. Tetraphase 30S subunit of TP-6076 Phase 16 Pharmaceuticals Tetracycline Yes Yes (CRE and CRAB) Bacterial infections bacterial ribosome Inc. VenatoRx Possibly VNRX-5133 Phase 1 β-lactamase inhibitor β-lactamase Possibly Bacterial infections Pharmaceuticals (CRE, CRPA, CRAB) Afabicin Debiopharm Benzofuran Acute bacterial skin and skin structure (Debio 1450)/ Phase 2 FabI12 No No International SA naphthyridine11 infections (Staphylococcus-specific) Debio 145216 Innovation Pharmaceuticals Acute bacterial skin and Brilacidin Phase 2 Defensin mimetic11 Cell membrane No No Inc. (formerly skin structure infections Cellceutix Corp.) Complicated urinary tract infections β-lactam including pyelonephritis, complicated Cefepime + (cephalosporin) + intra-abdominal infections, and Phase 2 Allecra PBP; β-lactamase Yes Possibly (CRE) AAI1019 β-lactamase inhibitor hospital-acquired bacterial pneumonia/ (β-lactam) ventilator-associated bacterial pneumonia CrystalGenomics Acute bacterial skin and CG400549 Phase 2 Benzyl pyridinone11 FabI12 No No Inc. skin structure infections Acute bacterial skin and skin structure MerLion Bacterial type II infections, complicated intra-abdominal Finafloxacin10 Phase 2 Pharmaceuticals Fluoroquinolone Yes No topoisomerase infections, and complicated urinary tract Pte Ltd. infections, including pyelonephritis Complicated urinary tract infections,6 Bacterial type II uncomplicated urinary tract infections,6 Gepotidacin GlaxoSmithKline topoisomerase acute bacterial skin and skin structure Phase 2 Triazaacenaphthylene11 No Yes (N. gonorrhoeae) (GSK2140944) PLC (novel A subunit infections, uncomplicated urogenital site)12 gonorrhea,6 and community-acquired bacterial pneumonia6 Continued on the next page Expected activity Expected activity against CDC Development against resistant Drug name Company Drug class Target urgent or WHO Potential indication(s)?5 phase2 Gram-negative critical threat ESKAPE pathogens?3 pathogen?4 β-lactam LYS228 Phase 2 Novartis Ag. PBP Yes Yes (CRE) Bacterial infections (monobactam) Ventilator-associated Murepavadin Antimicrobial peptide Phase 2 Polyphor Ltd. LptD12 Yes Yes (CRPA) bacterial pneumonia (caused (POL7080) mimetic11 by P. aeruginosa) Nafithromycin 50S subunit of Community-acquired Phase 2 Wockhardt Ltd. Macrolide No No (WCK 4873) bacterial ribosome bacterial pneumonia Community-acquired bacterial TaiGen Bacterial type II pneumonia, diabetic foot infection, Nemonoxacin7 Phase 2 Biotechnology Co. Quinolone No No topoisomerase and acute bacterial skin and skin Ltd. structure infections Otsuka Bacterial type II OPS-2071 Phase 2 Pharmaceutical Quinolone No Yes (C. difficile) C. difficile infection topoisomerase Co. Ltd. Ridinilazole Summit Phase 2 Bis-benzimidazole11 Unknown No Yes (C. difficile) C. difficile infection (SMT 19969) Therapeutics PLC WCK 771/ Bacterial type II Phase 26 Wockhardt Ltd. Fluoroquinolone No No Hospital-acquired bacterial pneumonia6 WCK 234916 topoisomerase Bacterial type II Zoliflodacin Entasis Phase 2 Spiropyrimidinetrione11 topoisomerase No Yes (N. gonorrhoeae) Uncomplicated gonorrhea (ETX0914) Therapeutics Inc. (GyrB)12 Actelion 50S subunit Pharmaceuticals of bacterial Ltd. (wholly owned Oxazolidinone- Cadazolid Phase 3 ribosome; No Yes (C. difficile) C. difficile infection subsidiary of quinolone hybrid bacterial type II Johnson & Johnson topoisomerase Services Inc.) Cefiderocol Siderophore-β-lactam Yes (CRE, CRAB, Phase 3 Shionogi & Co. Ltd. PBP Yes Complicated urinary tract infections (S-649266) (cephalosporin) and CRPA) R-Pharm/ Cefilavacin Glycopeptide-β-lactam PG chain Acute bacterial skin and Phase 36 Theravance No No (TD-1792) (cephalosporin) hybrid elongation; PBP skin structure infections Biopharma Inc. Continued on the next page Expected activity Expected activity against CDC Development against resistant Drug name Company Drug class Target urgent or WHO Potential indication(s)?5 phase2 Gram-negative critical threat ESKAPE pathogens?3 pathogen?4 Acute bacterial skin and skin structure Basilea β-lactam infections, community-acquired bacterial Ceftobiprole7 Phase 3 PBP Yes No Pharmaceutica (cephalosporin) pneumonia and hospital-acquired bacteria pneumonia Tetraphase 30S subunit of Yes (CRE); Complicated intra-abdominal infections Eravacycline Phase 3 Pharmaceuticals Tetracycline Yes bacterial ribosome possibly (CRAB) and complicated urinary tract infections Inc. Acute bacterial skin and skin structure Dihydrofolate Iclaprim Phase 3 Motif Bio PLC 2,4-diaminopyrimidine
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