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BAL30072

 
 

BAL30072 BAL30072 is a novel monosulfactam antibiotic in phase 1 with bactericidal activity against multidrug-resistant Gram-negative bacteria. It has demonstrated in-vitro and in-vivo coverage of Gram-negative pathogens including multidrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. It has robust activity against common strains of resistant pathogens including those that produce antibiotic-inactivating enzymes such as carbapenemases and metallo-beta-lactamases. BAL30072 has shown additive or synergistic activity with antibiotics from the carbapenem class.

Due to its potent antimicrobial activity against a broad range of clinically relevant Gram-negative bacteria, BAL30072 has the potential to be used for patients with serious and life-threatening infections such as hospital-acquired pneumonia (including ventilator-associated pneumonia), complicated intra-abdominal infections or complicated urinary tract infections.

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

Ongoing phase 1 program

To date, Basilea has conducted a single ascending dose, double-blind, randomized, placebo-controlled trial and double-blind, randomized, placebo-controlled dose-ranging studies with multiple ascending doses in healthy volunteers assessing the pharmacokinetics, safety and tolerability of BAL30072.

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 arsenal.

In hospitals, beta-lactam antibiotics form the main-stay antimicrobial therapy but their use is increasingly compromised by acquired beta-lactam resistance, especially in Gram-negative bacteria such as Enterobacteriaceae and Pseudomonas aeruginosa. In a recent survey involving thousands of patients from hospitals around the world, Gram-negative bacteria have been found in sixty percent of clinical isolates in intensive care units. The need for novel Gram-negative antibiotics with a broad coverage of clinically relevant pathogens is therefore undeniable.

 
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IDSA
Infectious Diseases
Society of America