Basilea initiates phase I clinical program of its novel antibiotic BAL30072
Basilea Pharmaceutica Ltd. announces that the first phase I study of its innovative sulfactam antibiotic BAL30072 has been initiated. This study investigates the pharmacokinetic profile, safety and tolerability of the compound in healthy volunteers. BAL30072 has broad antimicrobial activity against multidrug-resistant Gram-negative "superbugs" that are increasingly associated with potentially life-threatening infections in hospitals around the world.
"Basilea remains focused on developing novel hospital anti-infectives targeting the medical challenge of rising drug resistance. We are delighted to see this innovative antibiotic move forward from Basilea's own research as the third anti-infective in our clinical development pipeline," said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. "BAL30072 is designed to tackle the increasing problem of antibiotic-resistance in a broad range of Gram-negative bacteria associated with a wide variety of serious and life-threatening hospital infections."
The double-blind, randomized, placebo-controlled clinical phase I study investigates the pharmacokinetics, safety and tolerability of single ascending doses of BAL30072 in healthy male volunteers.
BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic with a unique mode of action, conferring potent bactericidal activity against Gram-negative pathogens. The compound can act like a "Trojan horse" by exploiting natural nutrient uptake systems of pathogens to gain access to its intracellular target.
BAL30072 is stable towards many types of beta-lactamase enzymes, including many of the extended-spectrum beta-lactamases (ESBLs) and metallo-beta-lactamases, which can deactivate most of the currently marketed beta-lactam antibiotics such as cephalosporins and carbapenems. The compound demonstrates potent antibacterial in-vitro and in-vivo activity against clinically increasingly problematic multi-resistant Gram-negative bacteria such as Pseudomonas aeruginosa, Acinetobacter spp., Klebsiella spp. and Enterobacter spp. These pathogens are associated with serious and life-threatening infections, including hospital-acquired pneumonia, complicated intra-abdominal infections or complicated urinary tract infections.
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