Basilea initiates multiple ascending dose phase I study with antibiotic BAL30072 active against multidrug-resistant Gram-negative bacteria

08-Sep-2011 - Switzerland

Basilea Pharmaceutica Ltd. announced the initiation of the second phase I study with its novel sulfactam antibiotic BAL30072.

Gram-negative pathogens account for more than a third of all hospital infections and over half of the infections occurring in intensive care units. Infections with multidrug-resistant Gram-negative bacteria are associated with increased mortality, prolonged hospital stays and higher healthcare costs.

"We are very excited by the development of BAL30072. It has the potential to fill the enormous treatment gap against resistant Gram-negative bacteria that are claiming the lives of patients in increasing numbers. This multiple dose study will build upon the excellent results from our first human study of BAL30072 and we aim to complete this second study in the first part of 2012," said Dr. Anthony Man, CEO of Basilea Pharmaceutica International Ltd.

BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo models demonstrated potent bactericidal activity against a broad range of multidrug-resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. It overcomes bacterial resistance by several mechanisms and is not easily destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum beta-lactamases (ESBLs), carbapenemases and the recently characterized New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance against many currently marketed antibiotics.

Following the successful completion of the single ascending dose phase I trial, in which BAL30072 was safe and well tolerated and displayed dose-proportional pharmacokinetic properties, Basilea is now commencing a double-blind, randomized, placebo-controlled study that assesses the pharmacokinetics, safety and tolerability of BAL30072 after multiple ascending intravenous infusions in healthy volunteers.

https://www.bionity.com/en/news/134267/basilea-initiates-multiple-ascending-dose-phase-i-study-with-antibiotic-bal30072-active-against-multidrug-resistant-gram-negative-bacteria.html