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Antibiotics Currently in Clinical Development

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Antibiotics Currently in Clinical Development A data table from Sept 2014 Antibiotics Currently in Clinical Development As of September 2014, an estimated 38 new antibiotics1 with the potential to treat serious bacterial infections are in clinical development for the U.S. market. The success rate for drug development is low; at best, only 1 in 5 candidates that enter human testing will be approved for patients.* This snapshot of the antibiotic pipeline will be updated periodically as products advance or are known to drop out of development. Please contact Rachel Zetts at [email protected] or 202-540-6557 with additions or updates. Cited for potential Development Known QIDP4 Drug name Company Drug class activity against gram- Potential indication(s)?5 phase2 designation? negative pathogens?3 Approved (for acute Acute bacterial skin and skin structure bacterial skin and skin infections, hospital-acquired bacterial Tedizolid Cubist Pharmaceuticals Oxazolidinone Yes structure infections), pneumonia/ventilator-acquired bacterial June 20, 2014 pneumonia Approved, May 23, Acute bacterial skin and skin structure Dalbavancin Durata Therapeutics Lipoglycopeptide Yes 2014 infections Approved, August 6, Acute bacterial skin and skin structure Oritavancin The Medicines Company Glycopeptide Yes 2014 infections New Drug Application (NDA) submitted (for Complicated urinary tract infections, complicated urinary complicated intra-abdominal infections, Novel cephalosporin+beta- Ceftolozane+tazobactam8 tract infection and Cubist Pharmaceuticals Yes Yes acute pyelonephritis (kidney infection), lactamase inhibitor complicated intra- hospital-acquired bacterial pneumonia/ abdominal infection ventilator-associated pneumonia indications) NDA submitted (for Complicated urinary tract infections, complicated urinary AstraZeneca/Forest complicated intra-abdominal infections, Ceftazidime+avibactam Cephalosporin+novel beta- tract infections and Laboratories (acquired by Yes Yes acute pyelonephritis (kidney infection), (CAZ-AVI)8 lactamase inhibitor complicated intra- Actavis) hospital-acquired bacterial pneumonia/ abdominal infections) ventilator-associated bacterial pneumonia Fabl inhibitor (Debio 1452 Acute bacterial skin and skin structure Debio 1450 Phase 1 Debiopharm Group Yes pro-drug) infections AZD0914 Phase 1 AstraZeneca DNA gyrase inhibitor Yes Yes Uncomplicated gonorrhea AstraZeneca/Forest Aztreonam+avibactam7 Monobactam+novel beta- Phase 1 Laboratories (acquired by Yes Bacterial infections (ATM-AVI) lactamase inhibitor Actavis) Cited for potential Development Known QIDP4 Drug name Company Drug class activity against gram- Potential indication(s)?5 phase2 designation? negative pathogens?3 Multidrug-resistant Gram-negative bacterial BAL30072 Phase 1 Basilea Pharmaceutica Monosulfactam Yes infections6 Methionyl-tRNA CRS3123 Phase 1 Crestone synthetase (MetRS) Clostridium difficile infection inhibitor EDP-788 Phase 1 Enanta Pharmaceuticals Bicyclolide Bacterial infections LegoChem Biosciences LCB01-0371 Phase 111 Oxazolidinone Bacterial infections (South Korea) Bacterial infections including community- MRX-I Phase 1 MicuRx Pharmaceuticals Oxazolidinone acquired MRSA and vancomycin-resistant enterococci infections6 Serious Gram-positive bacterial infections (acute bacterial skin and skin structure Glycopeptide- TD-1607 Phase 1 Theravance Biopharma infections, hospital-acquired pneumonia/ cephalosporin heterodimer ventilator-associated pneumonia, bacteremia)6 Fluoroquinolone (WCK 771 WCK 2349 Phase 1 Wockhardt Yes Bacterial infections pro-drug) WCK 771 Phase 1 Wockhardt Fluoroquinolone Yes Bacterial infections Ventilator-associated bacterial pneumonia, Polyphor (Roche Macrolide (protein epitope POL7080 Phase 2 Yes (Pseudomonas) lower respiratory tract infection, licensee) mimetic) LptD inhibitor bronchiectasis Acute bacterial skin and skin structure Debio 1452 Phase 2 Debiopharm Group Fabl inhibitor Yes infections Community-acquired bacterial pneumonia, Furiex Pharmaceuticals Avarofloxacin Phase 2 Fluoroquinolone Yes Yes acute bacterial skin and skin structure (subsidiary of Actavis) infections Acute bacterial skin and skin structure Brilacidin Phase 2 Cellceutix Defensin-mimetic infections AstraZeneca/Forest Cephalosporin+novel beta- Ceftaroline+avibactam8 Phase 2 Laboratories (acquired by Yes Complicated urinary tract infections lactamase inhibitor Actavis) Acute bacterial skin and skin structure CG-400549 Phase 2 CrystalGenomics Fabl inhibitor infections, osteomyelitis6 Complicated urinary tract infections, acute pyelonephritis (kidney infection), acute Finafloxacin Phase 2 MerLion Pharmaceuticals Fluoroquinolone Yes Yes intra-abdominal infections, acute bacterial skin and skin structure infections Cited for potential Development Known QIDP4 Drug name Company Drug class activity against gram- Potential indication(s)?5 phase2 designation? negative pathogens?3 Type 2 topoisomerase Respiratory tract infections, acute bacterial GSK2140944 Phase 2 GlaxoSmithKline inhibitor skin and skin structure infections Acute bacterial skin and skin structure Lefamulin (BC-3781) Phase 2 Nabriva Therapeutics Pleuromutilin infections, community-acquired bacterial pneumonia6 Complicated urinary tract infections, acute Relebactam (MK- pyelonephritis, complicated intra-abdominal Carbapenem+novel beta- 7655)+(imipenem/ Phase 2 Merck Yes Yes infections, hospital-acquired bacterial lactamase inhibitor cilastatin)8 pneumonia/ventilator-associated bacterial pneumonia Community-acquired bacterial pneumonia, Nemonoxacin9 Phase 2 TaiGen Biotechnology Quinolone Yes Yes diabetic foot infection, acute bacterial skin and skin structure infections Community-acquired bacterial pneumonia, acute bacterial skin and skin structure Omadacycline Phase 2 Paratek Pharmaceuticals Tetracycline Yes Yes infections, complicated urinary tract infections Acute bacterial skin and skin structure Radezolid Phase 2 Melinta Therapeutics Oxazolidinone Yes Yes infections, community-acquired bacterial pneumonia C. difficile-associated diarrhea,6 C. difficile Ramoplanin Phase 2 Nanotherapeutics Lipoglycopeptide relapse prevention6 TAKSTA (fusidic acid)10 Phase 2 Cempra Pharmaceuticals Fusidane Prosthetic joint infections Acute bacterial skin and skin structure infections, other serious infections caused by Glycopeptide- TD-1792 Phase 2 Theravance Gram-positive bacteria including hospital- cephalosporin heterodimer acquired pneumonia/ventilator-associated pneumonia and bacteremia6 Dong Wha Zabofloxacin Phase 2 Fluoroquinolone Community-acquired bacterial pneumonia Pharmaceutical SMT 19969 Phase 2 Summit Yes C. difficile-associated diarrhea Cadazolid Phase 3 Actelion Pharmaceuticals Quinolonyl-oxazolidinone Yes C. difficile-associated diarrhea Complicated urinary tract infections, complicated intra-abdominal infections, Rempex Pharmaceuticals hospital-acquired bacterial pneumonia/ (wholly owned subsidiary Carbapenem+novel boronic ventilator-associated bacterial pneumonia, Carbavance8 Phase 3 Yes Yes of The Medicines beta-lactamase inhibitor febrile neutropenia, bacteremia, acute Company) pyelonephritis (some indications specifically target infections caused by carbapenem- resistant Enterobacteriaceae) Cited for potential Development Known QIDP4 Drug name Company Drug class activity against gram- Potential indication(s)?5 phase2 designation? negative pathogens?3 Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, uncomplicated gonorrhea, Delafloxacin Phase 3 Melinta Therapeutics Fluoroquinolone Yes Yes hospital-acquired bacterial pneumonia,6 complicated urinary tract infections,6 complicated intra-abdominal infections6 Complicated intra-abdominal infections, Tetraphase Eravacycline8 Phase 3 Tetracycline Yes Yes complicated urinary tract infections, Pharmaceuticals hospital-acquired bacterial pneumonia6 Bloodstream infections and nosocomial Plazomicin8 Phase 3 Achaogen Aminoglycoside Yes pneumonia caused by carbapenem-resistant Enterobacteriaceae Community-acquired bacterial pneumonia, Solithromycin Phase 3 Cempra Pharmaceuticals Macrolide (ketolide) Yes Yes uncomplicated urogenital gonorrhea Surotomycin Phase 3 Cubist Pharmaceuticals Lipopeptide Yes C. difficile-associated diarrhea Note: The following drugs have been removed from the pipeline. They will be included in future updates if development resumes: September 2014 Review: GSK-2696266 and GSK-1322322 (GlaxoSmithKline), ACHN-975 (Achaogen), and LFF571 (Novartis) were removed during the September 2014 review. These drugs were either no longer included in the R&D pipelines on the company website or there was communication from the company regarding the status of the drugs. June 2014 Review: Ceftobiprole—an antibiotic developed by Basilea Pharmaceutica—had been included in our analysis; however, the company announced in June 2014 that it is not pursuing further development in the United States until a partner has been acquired. * Michael Hay et al., “Clinical Development Success Rates for Investigational Drugs,” Nature Biotechnology 32, no. 1 (2014): 40-51. See more at http://www.pewtrusts.org/en/multimedia/data-visualizations/2014/ antibiotics-currently-in-clinical-development. Notes 1. Antibiotics listed here include products containing at least one component not approved in 3. Based on information provided on the company website or press releases or based on inclusion the United States previously. All analyses were strictly limited to systemic antibiotics (drugs in citations iv or v below. “Yes” in this category means that the antibiotic has potential
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