Antibiotics maker Achaogen announced today that it has landed a $60 million contract option from the federal Biomedical Advanced Research and Development Authority (BARDA) to further the development of its drug plazomicin to treat patients with serious Gram-negative bacterial infections.
The contract extends San Francisco-based Achaogen's original deal with BARDA, awarded in September 2010 with initial committed funding of $27 million. In 2012, BARDA extended the contract to $16 million. The new option brings the total value of the contract to $103 million. Under the agreement, Achaogen will conduct a global Phase III superiority study to evaluate the efficacy and safety of plazomicin. The study is expected to begin at the end of 2013.
Gram-negative bacilli (GNB) bacteria--which include E. coli, salmonella, and Shigella as well as Enterobacteriaceae bacteria--have gotten the attention of health officials as of late. The so-called nightmare bacteria are growing increasingly resistant to drugs. In March, the Centers for Disease Control and Prevention alerted the public about a deadly kind of GNB called carbapenem-resistant Enterobacteriaceae, or CRE, which is known to spread in healthcare facilities and kill up to half of patients who get bloodstream infections from them.
"The growing prevalence of CRE infections poses a substantial public health threat, given the high mortality rates associated with CRE infections. Plazomicin's strong potential to address this public health issue and to contribute to the global effort to guard against bacterial biothreats makes it a critically important agent in the antibacterial pipeline," said Achaogen CEO Kenneth Hillan in a statement.
Just last week, the Infectious Diseases Society of America released a report outlining the rise in antibiotic resistance in the U.S. and expressed concern over the lack of antibiotics currently in development to fight these superbugs. The Achaogen clinical study represents a step toward addressing this unmet medical need for multi-drug-resistant bacterial infections.
Achaogen's plazomicin is a next-generation aminoglycoside antibiotic engineered to disable key aminoglycoside resistance mechanisms. Its bactericidal activity is designed to fight off Gram-negative pathogens, including strains resistant to carbapenem antibiotics--one of the last lines of defense against resistant infections. Plazomicin is also being developed to treat infections caused by certain biothreat agents, including Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia.
- here's the press release