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BAL30072

 
 

BAL30072 BAL30072 is an investigational intravenous (i.v.) monosulfactam antibiotic with bactericidal activity against multidrug-resistant Gram-negative bacteria. It is currently in phase 1 clinical development.

The drug demonstrated in-vitro and in-vivo coverage of Gram-negative pathogens including multidrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa and it is active against strains that produce antibiotic-inactivating enzymes such as metallo-beta-lactamases.1 In-vitro data showed synergistic or additive activity of BAL30072 with antibiotics from the carbapenem class.2

In June 2013, Basilea entered a contract for the development of BAL30072 with the Biomedical Advanced Research and Development Authority (BARDA), a division within the U.S. Department of Health and Human Services, which may provide development funding of up to USD 89 million.

Ongoing phase 1 program
In June 2014, a phase 1 clinical study was initiated, evaluating the safety, tolerability, and pharmacokinetics of multiple-ascending doses of i.v. BAL30072 in combination with meropenem, a carbapenem antibiotic. Previous phase 1 studies determined the maximum tolerated dose for BAL30072, with reversible elevated liver enzyme levels as the dose-limiting factor.

The need for new Gram-negative antibiotics
Antibiotic-resistance is a recurring issue in the infectious disease field. Many pathogens will eventually develop mechanisms that enable them to deactivate even the most potent antibiotics in the medical armamentarium.

Beta-lactam antibiotics form the main-stay of antimicrobial therapy in the hospital but their use is increasingly compromised by acquired beta-lactam resistance, especially in Gram-negative bacteria such as Enterobacteriaceae and Pseudomonas aeruginosa. In a study involving thousands of patients from hospitals around the world, Gram-negative bacteria were found in sixty percent of clinical isolates in intensive care units.3 Therefore there is a high need for novel Gram-negative antibiotics with a broad coverage of clinically relevant pathogens.


References

1. M. G. P. Page et al. In vitro properties of BAL30072, a novel siderophore sulfactam with activity against multiresistent Gram-negative bacilli. Antimicrobial Agents and Chemotherapy 2010 (54), 2291-2302
2. I. Morissey et al. Activity of BAL30072 alone and in combination with carbapenems against Gram-negative bacteria. European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2014, poster P0296
3. J. L. Vincent et al. International study of the prevalence and outcomes of infection in intensive care units. Journal of the American Medical Association 2009 (302), 2323-2329

 
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IDSA
Infectious Diseases
Society of America