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Basilea Pharmaceutica AG Initiates Next Phase 1 Multiple Ascending Dose Study With Antibiotic Bal30072 Active Against Multidrug-Resistant Gram-Negative Bacteria


Thursday, 22 Nov 2012 01:51am EST 

Basilea Pharmaceutica AG announced that it has initiated the next planned pharmacokinetic phase 1 healthy volunteer study in its clinical development program for BAL30072, Basilea's new investigational antibiotic with activity against multidrug-resistant Gram- negative bacteria. Gram-negative pathogens account for approximately half of all hospital- acquired bacterial infections. Many Gram-negative pathogens have acquired the ability to produce enzymes that destroy beta-lactam antibiotics, which have been the mainstay of antibiotic therapy for several decades. Multidrug-resistant bacteria for which there are few or no therapeutic options available are being encountered with increasing frequency and are associated with increased mortality, prolonged hospital stays and higher healthcare costs. BAL30072 is a novel injectable sulfactam antibiotic that in in-vitro and in-vivo models demonstrated potent bactericidal activity against a broad range of clinically relevant multidrug-resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. BAL30072 overcomes several mechanisms of bacterial resistance. In particular, it is not easily destroyed by bacterial enzymes such as extended-spectrum beta-lactamases (ESBLs), carbapenemases or the New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance to many marketed antibiotics.