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Antibiotics Currently in Clinical Development

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A data table from Dec 2015 Antibiotics Currently in Clinical Development As of September 2015, an estimated 39 new antibiotics1 with the potential to treat serious bacterial infections are in clinical development for the U.S. market and two have been approved within the last year. The success rate for clinical drug development is low; at best, only 1 in 5 candidates 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 an external expert. It will be updated periodically, as products advance or are known to drop out of development. Because this list is updated periodically, footnote numbers may not be sequential. Please contact [email protected] with additions or updates. Expected activity Expected activity Development against resistant against a CDC Drug name Company Drug class Potential indication(s)?5 phase2 Gram-negative ESKAPE urgent threat pathogens?3 pathogen?4 Approved for: complicated urinary tract Cubist Pharmaceuticals, infections, complicated intra-abdominal Novel Ceftolozane+Tazobactam Approved Dec. 19, Inc. (wholly owned infections, acute pyelonephritis (kidney cephalosporin+beta- Yes No (Zerbaxa) 2014 subsidiary of Merck & infection); other potential indications: lactamase inhibitor Co.) hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia Approved for: complicated urinary tract infections, complicated intra-abdominal infections, acute pyelonephritis (kidney Ceftazidime+Avibactam Approved Feb. 25, Allergan plc (formerly Cephalosporin + novel Yes Yes infection); other potential indications: (Avycaz) 201513 Actavis)/AstraZeneca plc beta-lactamase inhibitor hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia, bacteremia WCK 4873 Phase 1 Wockhardt Ltd. No No Bacterial infections17 MGB-BP-3 Phase 110 MGB Biopharma Ltd. No Yes C. difficile infections Meiji Seika Pharma Co., Ltd./Fedora OP0595 (RG6080) Phase 110 Beta-lactamase inhibitor Possibly Possibly Bacterial infections Pharmaceuticals, Inc. (Roche licensee) Aztreonam+Avibactam7 AstraZeneca/Allergan Monobactam + novel Phase 110 Yes Yes Bacterial infections (ATM-AVI) (formerly Actavis) beta-lactamase inhibitor Basilea Pharmaceutica Multidrug-resistant Gram-negative bacterial BAL30072 Phase 1 Monosulfactam Yes Yes Ltd. infections6 Methionyl-tRNA CRS3123 Phase 1 Crestone, Inc. synthetase (MetRS) No Yes C. difficile infections inhibitor Expected activity Expected activity Development against resistant against a CDC Drug name Company Drug class Potential indication(s)?5 phase2 Gram-negative ESKAPE urgent threat pathogens?3 pathogen?4 LegoChem Biosciences, LCB01-0371 Phase 110 Oxazolidinone No No Bacterial infections Inc. Acute bacterial skin and skin structure Glycopeptide- Theravance Biopharma, infections,6 hospital-acquired pneumonia/ TD-1607 Phase 1 cephalosporin No No Inc. ventilator-associated pneumonia,6 heterodimer bacteremia6 Fluoroquinolone (WCK WCK 2349 Phase 1 Wockhardt Ltd. No No Bacterial infections17 771 pro-drug) WCK 771 Phase 1 Wockhardt Ltd. Fluoroquinolone No No Bacterial infections17 MicuRx Pharmaceuticals, Acute bacterial skin and skin structure MRX-I Phase 216 Oxazolidinone No No Inc. infections Fabl inhibitor (Debio Acute bacterial skin and skin structure Debio 1450 Phase 2 Debiopharm Group No No 1452 pro-drug) infections (staphylococci-specific) Spiropyrimidinetrione ETX0914 Phase 2 Entasis Therapeutics, Inc. No Yes Uncomplicated gonorrhea DNA gyrase inhibitor S-649266 Phase 2 Shionogi, Inc. Cephalosporin Yes Yes Complicated urinary tract infections Macrocycle (protein Ventilator-associated bacterial pneumonia POL7080 Phase 210 Polyphor Ltd. epitope mimetic) LptD Yes (Pseudomonas) No (caused by Pseudomonas aeruginosa), lower inhibitor respiratory tract infection, bronchiectasis Acute bacterial skin and skin structure Debio 1452 Phase 2 Debiopharm Group Fabl inhibitor No No infections (staphylococci-specific) Community-acquired bacterial pneumonia, Allergan plc (formerly Avarofloxacin Phase 2 Fluoroquinolone No No acute bacterial skin and skin structure Actavis) infections Acute bacterial skin and skin structure Brilacidin Phase 2 Cellceutix Corp. Defensin-mimetic No No infections AstraZeneca plc/Allergan Cephalosporin + novel Ceftaroline+Avibactam Phase 2 Yes Yes Bacterial infections6 plc (formerly Actavis) beta-lactamase inhibitor Acute bacterial skin and skin structure CG400549 Phase 2 CrystalGenomics, Inc. Fabl inhibitor No No infections, osteomyelitis6 Complicated urinary tract infections, acute pyelonephritis (kidney infection), MerLion Pharmaceuticals Finafloxacin11 Phase 212 Fluoroquinolone Yes 14 Possibly15 complicated intra-abdominal infections, Pte Ltd. acute bacterial skin and skin structure infections Respiratory tract infections, acute Gepotidacin Novel bacterial Phase 2 GlaxoSmithKline plc No Yes bacterial skin and skin structure infections, (GSK2140944) topoisomerase inhibitor uncomplicated urogenital gonorrhea Expected activity Expected activity Development against resistant against a CDC Drug name Company Drug class Potential indication(s)?5 phase2 Gram-negative ESKAPE urgent threat pathogens?3 pathogen?4 Community-acquired bacterial pneumonia, TaiGen Biotechnology Nemonoxacin8 Phase 2 Quinolone No No diabetic foot infection, acute bacterial skin Co., Ltd. and skin structure infections Acute bacterial skin and skin structure Melinta Therapeutics, Radezolid Phase 2 Oxazolidinone No No infections, community-acquired bacterial Inc. pneumonia Ramoplanin Phase 2 Nanotherapeutics, Inc. Glycolipodepsipeptide No Yes C. difficile relapse prevention6 Dong Wha Zabofloxacin Phase 2 Fluoroquinolone No No Community-acquired bacterial pneumonia Pharmaceutical Co., Ltd Summit Therapeutics, SMT 19969 Phase 2 No Yes C. difficile-associated diarrhea Inc. Community-acquired bacterial pneumonia, Paratek Pharmaceuticals, acute bacterial skin and skin structure Omadacycline Phase 3 Tetracycline Yes Possibly15 Inc. infections, complicated urinary tract infections Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, hospital-acquired bacterial Lefamulin (BC-3781) Phase 3 Nabriva Therapeutics AG Pleuromutilin No No pneumonia/ventilator-associated bacterial pneumonia, osteomyelitis,6 prosthetic joint infections6 Complicated urinary tract infections, acute Imipenem/ pyelonephritis, complicated intra-abdominal Carbapenem + novel cilastatin+relebactam Phase 316 Merck & Co., Inc. Yes Yes infections, hospital-acquired bacterial beta-lactamase inhibitor (MK-7655) pneumonia/ventilator-associated bacterial pneumonia Acute bacterial skin and skin structure Dihydrofolate reductase Iclaprim Phase 318 Motif Bio plc No No infections; hospital-acquired bacterial (DHFR) inhibitor pneumonia Actelion Pharmaceuticals Quinolonyl- Cadazolid Phase 3 No Yes C. difficile-associated diarrhea Ltd oxazolidinone Prosthetic joint infections, acute bacterial Taksta (Fusidic acid)9 Phase 3 Cempra, Inc. Fusidane No No skin and skin structure infections Complicated urinary tract infections, complicated intra-abdominal infections, Rempex Pharmaceuticals, hospital-acquired bacterial pneumonia/ Meropenem + novel Carbavance Inc. (wholly owned ventilator-associated bacterial pneumonia, Phase 3 boronic beta-lactamase Yes Yes (RPX7009+meropenem) subsidiary of The febrile neutropenia, bacteremia, acute inhibitor Medicines Co.) pyelonephritis (some indications specifically target infections caused by carbapenem- resistant Enterobacteriaceae ) Expected activity Expected activity Development against resistant against a CDC Drug name Company Drug class Potential indication(s)?5 phase2 Gram-negative ESKAPE urgent threat pathogens?3 pathogen?4 Acute bacterial skin and skin structure infections, hospital-acquired bacterial Melinta Therapeutics, Delafloxacin Phase 3 Fluoroquinolone Possibly Possibly pneumonia,6 complicated urinary tract Inc. infections,6 complicated intra-abdominal infections6 Complicated intra-abdominal infections, Tetraphase Eravacycline Phase 3 Tetracycline Yes Yes complicated urinary tract infections, Pharmaceuticals, Inc. hospital-acquired bacterial pneumonia6 Complicated urinary tract infections, catheter-related bloodstream infections, hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia, Plazomicin Phase 3 Achaogen, Inc. Aminoglycoside Yes Yes complicated intra-abdominal infections, acute pyelonephritis (kidney infection) (some indications specifically target infections caused by carbapenem-resistant Enterobacteriaceae) Community-acquired bacterial pneumonia, Macrolide Solithromycin Phase 3 Cempra, Inc. No Yes uncomplicated urogenital gonorrhea, (fluoroketolide) urethritis6 Cubist Pharmaceuticals, Inc. (wholly owned Surotomycin Phase 3 Lipopeptide No Yes C. difficile-associated diarrhea subsidiary of Merck & Co.) For definitions of drug development terms, visit: http://www.pewtrusts.org/en/research-and-analysis/analysis/2014/03/12/from-lab-bench-to-bedside-a-backgrounder-on-drug-development. Note: The following drugs have been removed from the pipeline. They will be included in future updates if development resumes: September 2015 review: No changes. March 2015 review: No changes. 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