Achaogen, a biopharmaceutical company focused on discovering, developing and commercializing treatments for serious infections caused by multi-drug resistant gram-negative bacteria, has been awarded a $60 million contract option from the Biomedical Advanced Research and Development Authority (BARDA). The option supports the conduct of a global phase III study to evaluate the efficacy and safety of plazomicin in treating patients with gram-negative bacterial infections due to CRE.
This pathogen-specific study represents a new development approach to address unmet medical needs for multi-drug resistant bacterial infections. The study is expected to start in the fourth quarter.
"The growing prevalence of CRE infections poses a substantial public health threat, given the high mortality rates associated with CRE infections,” said Kenneth J. Hillan, M.B. Ch.B., chief executive officer and chief medical officer of Achaogen.
Plazomicin is a next-generation aminoglycoside antibiotic engineered to overcome aminoglycoside resistance mechanisms. It has bactericidal activity against gram-negative pathogens, including strains resistant to carbapenem antibiotics—a last line of defense against resistant infections. Plazomicin is also being developed for the treatment of infections caused by biothreat agents, including Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia.
The option was issued under BARDA's Broad Spectrum Antimicrobials (BSA) program, extending Achaogen's original contract awarded in September of 2010 with initial committed funding of $27 million. In 2012, BARDA exercised an additional $16 million contract option. The new option brings the total value of the contract to $103 million.