- Contract to fund Phase 3 superiority study of plazomicin in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections -
South San Francisco, CA, April 24, 2013 – Achaogen, Inc. today announced the award of a $60M contract option from the Biomedical Advanced Research and Development Authority (BARDA). The option supports the conduct of a global Phase 3 superiority study that will evaluate the efficacy and safety of plazomicin in treating patients with serious gram-negative bacterial infections due to CRE. This pathogen-specific clinical study represents a new development approach to address unmet medical needs for multi-drug resistant bacterial infections. The study is expected to start in fourth quarter of 2013.
“We are excited and honored to continue the development of plazomicin in partnership with BARDA,” said Kenneth J. Hillan, M.B. Ch.B., Chief Executive Officer and Chief Medical Officer of Achaogen. “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.”
Plazomicin is a next-generation aminoglycoside antibiotic that Achaogen engineered to overcome key aminoglycoside resistance mechanisms. It has potent bactericidal activity against important gram-negative pathogens, including strains resistant to carbapenem antibiotics – one of the last lines of defense against resistant infections. Plazomicin is also being developed for the treatment of infections caused by certain biothreat agents, including Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia.
The contract 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 $27M. In 2012, BARDA exercised an additional $16M contract option. The new option announced today brings the total value of the contract to $103M.
Achaogen is a biopharmaceutical company dedicated to discovering, developing, and commercializing treatments for serious infections caused by multi-drug resistant (MDR) gram-negative bacteria. In addition to plazomicin, the company's pipeline includes ACHN-975, a first-in-class LpxC enzyme inhibitor which is currently in Phase 1 clinical development. Achaogen has established and maintained its specialized research and development capabilities using a blend of funding from private investors and partnerships with governmental entities, including BARDA, the National Institute of Allergy and Infectious Diseases, and the U.S. Department of Defense. For more information, please visit the company’s website at www.achaogen.com.
Jennifer Cheung, Achaogen
Dennis Hom, Achaogen