The U.S. federal government has awarded a notable contract related to the field of chemical, biological, radiological and nuclear (CBRN) defense or life science research of interest for potential applications in biodefense:
The Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract valued at $88,884,306 to Basilea Pharmaceutica International, Ltd. for the research and development of BAL30072, a novel monosulfactam for the treatment of infections caused by multi-drug resistant gram-negative bacterial pathogens.
BAL30072 is being developed for the treatment of severe infections, such as nosocomial pneumonia due to multidrug-resistant Gram-negative bacteria. To date, 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 assessing 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 pre-clinical in-vitro and in animal studies, an additive or synergistic activity of BAL30072 when combined with antibiotics from the carbapenem class has been demonstrated. Under the contract with BARDA, Basilea will now continue to test in phase 1 safety and tolerability of BAL30072 also in combination with carbapenems. Basilea is continuing the profiling of BAL30072 to establish the optimal dosing regimens for clinical testing of combinations. The phase 1 development program, including studies in combination and in special patient populations, will continue in 2014.
Under the terms of the contract, BARDA will provide funding of approximately 17 million dollars over the initial agreement period of twenty-two months. Subsequent options which may be exercised over a total six-year-period would bring the total value of the contract up to 89 million. Exercise of these options is conditioned upon successful completion of pre-defined milestones, including microbiological, pre-clinical, clinical, manufacturing and associated regulatory activities.
“BAL30072 is a potent, bactericidal antibiotic covering a broad range of clinically relevant multidrug-resistant Gram-negative bacteria,” said Ronald Scott, Basilea’s Chief Executive Officer. “Through the BARDA contract, we will move forward with the development of our innovative antibiotic BAL30072, advancing a medical countermeasure for a potential biological threat to national security and public health.”
The award was announced under BARDA-CBRN-BAA-100-SOL-0009.