Basilea Pharmaceutica Ltd.  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 recognised as a global health threat. In preclinical studies, BAL30072 demonstrated synergistic or additive effects when combined with carbapenem antibiotics.

Prof. Achim Kaufhold, Basilea's chief medical officer, stated: "Based on the recent encouraging preclinical data on the synergistic or additive effects of BAL30072 and carbapenems we are exploring such combinations in the clinical setting. We are assessing the safety and tolerability of BAL30072 alone and in combination with meropenem in preparation for phase 2 development. Combinations with meropenem may add synergistic or additive coverage to the potent activity of BAL30072 against a broad range of clinically relevant multidrug-resistant Gram-negative pathogens, such as Acinetobacter baumannii and Pseudomonas aeruginosa and other less common pathogens causing serious infections for which there are currently few or no treatments available."

The phase 1 study is designed as a double blind, placebo-controlled, parallel-group study enrolling healthy female and male adults and randomised to receive multiple-ascending doses of BAL30072 or placebo alone or in combination with meropenem.

BAL30072 is an intravenous monosulfactam antibiotic in phase 1 clinical development 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. 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.