Date: 2014-06-12
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of a phase 1 combination study
Company: Basilea Pharmaceutica (Switzerland)
Product: BAL30072 in combination with meropenem
Action
mechanism: BAL30072 is an intravenous sulfactam antibiotic with bactericidal activity against infections by multidrug-resistant Gram-negative bacteria. The investigational drug demonstrated in-vitro and in-vivo coverage of Gram-negative pathogens including multidrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa and has robust activity against strains that produce antibiotic-inactivating enzymes such as metallo-beta-lactamases. BAL30072 has shown synergistic or additive activity with antibiotics from the carbapenem class. In previous phase 1 studies, the maximum tolerated dose for BAL30072 was determined, with reversible elevated liver enzyme levels as the dose-limiting factor.
Disease: infections with multidrug-resistant Gram-negative bacteria
Therapeutic area: Infectious diseases
Country:
Trial
details: The phase 1 study is designed as a double blind, placebo-controlled, parallel-group study enrolling healthy female and male adults and randomized to receive multiple-ascending doses of BAL30072 or placebo alone or in combination with meropenem.
Latest
news: * On June 12, 2014, Basilea Pharmaceutica has initiated a phase 1 clinical study with its Gram-negative antibiotic BAL30072 evaluating the safety, tolerability and pharmacokinetics of multiple-ascending doses of intravenously administered BAL30072 in combination with meropenem, an antibiotic of the carbapenem class. Basilea is developing BAL30072 for the potential treatment of infections with multidrug-resistant Gram-negative bacteria. Gram-negative pathogens account for approximately a third of all hospital-acquired infections and are recognized as a global health threat. In preclinical studies, BAL30072 demonstrated synergistic or additive effects when combined with carbapenem antibiotics.
In June 2013, Basilea entered a contract for the development of BAL30072 with the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services\' Office of the Assistant Secretary for Preparedness and Response. The contract may provide development funding for BAL30072 of up to USD 89 million.
