Basilea Pharmaceutica Ltd. Logo
 

BAL30072

 
 

BAL30072 BAL30072 is an investigational intravenously administered 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, resulting in broader Gram-negative coverage.2

The development of BAL30072 is conducted under a contract with the U.S. 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
BAL30072 is being investigated in a phase 1 clinical study, evaluating the safety, tolerability, and pharmacokinetics of multiple-ascending doses of intravenously administered BAL30072 alone and 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. Many Gram-negative pathogens have acquired the ability to produce enzymes, so-called beta-lactamases that destroy beta-lactam antibiotics, which have been the mainstay of antibiotic therapy for several decades.

The most serious Gram-negative infections are healthcare-associated.3 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.4 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. U.S. Centers for Disease Control (CDC). Antibiotic resistance threats in the United States, 2013. www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf [Accessed Oct. 16, 2014]
4. 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
 

 
Info
 
 
 

IDSA
Infectious Diseases
Society of America