Basilea Pharmaceutica won an up-to-$89 million contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) toward development of BAL30072, an antibiotic designed to fight multidrug-resistant Gram-negative pathogens, including those that pose a biothreat.
BARDA agreed to fund Basilea about $17 million over an initial agreement period of 22 months, with options over six years that could see the company obtaining up to an additional $72 million toward developing the new monosulfactam antibiotic. Exercise of the options is conditioned upon successful completion of predefined undisclosed milestones, including microbiological, preclinical, clinical, manufacturing, and associated regulatory activities.
Basilea is developing BAL30072 for treatment of severe infections—such as hospital-acquired pneumonia (including ventilator-associated pneumonia), complicated intra-abdominal infections or complicated urinary tract infections—due to multidrug-resistant bacteria that include Pseudomonas aeruginosa, Acinetobacter species, Klebsiella species, and Enterobacter species.
Basilea has conducted a single ascending-dose, double-blind, randomized, placebo-controlled trial and double-blind, randomized, placebo-controlled dose-ranging studies with multiple ascending doses in healthy volunteers.
The trial and studies are both intended to assess the pharmacokinetics, safety, and tolerability of BAL30072. For the current multiple ascending-dose study, the maximum tolerated dose has been reached. Consistent with previous findings the dose-limiting factor was reversible elevated liver enzyme levels. In earlier preclinical in vitro and in animal studies, Basilea said it has demonstrated additive or synergistic activity of BAL30072 when combined with carbapenem-class antibiotics.
Under its new contract with BARDA, Basilea will continue its Phase I safety and tolerability tests for BAL30072, also in combination with carbapenems. Basilea is also looking to establish optimal dosing regimens for clinical testing of combinations. Basilea said it plans to continue next year its Phase I development program, including studies in combination and in special patient populations.
“The drug has the potential of becoming an important treatment option for serious infections, including hospital-acquired infections due to resistant pathogens, which are increasing in frequency. BAL30072 addresses the global concerns of antibiotic resistance and also has a potential role in biodefense, treating infections caused by potential biowarfare agents,” Prof. Achim Kaufhold, Basilea’s CMO, said in a statement.