Achaogen, Inc, a biopharmaceutical company, has reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a phase III clinical trial of plazomicin in patients with serious multi-drug resistant (MDR) gram-negative bacterial infections. This phase III trial is designed as a superiority study to evaluate the efficacy and safety of plazomicin compared with colistin in patients with bloodstream infections and nosocomial pneumonia caused by Carbapenem-Resistant Enterobacteriaceae (CRE).
SPA agreement from the FDA indicates that the design and planned analyses of the clinical trial address objectives necessary to support a new drug application (NDA).
“Reaching agreement with the FDA on the plazomicin phase III study design is a significant milestone for Achaogen as well as a meaningful step forward in antibiotic drug development for new regulatory pathways that address serous unmet medical needs,” said Kenneth Hillan, MB Ch.B, chief executive officer and chief medical officer for Achaogen. “FDA agreement on this protocol provides a clear path for a streamlined development plan for plazomicin. The trial is expected to start in fourth quarter, 2013.”
CRE are a global and growing public health concern. These bacteria are resistant to nearly all available antibiotics, including carbapenems, one of the last lines of defense against resistant infections. Mortality rates approach 50 per cent in CRE patients with bloodstream infections, and the US Centres for Disease Control and Prevention has categorized CRE as an “urgent” public health threat requiring immediate and aggressive action.
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 CRE. Plazomicin is also being developed for the treatment of infections caused by certain biothreat agents, including Yersinia pestis and Francisella tularensis (which cause plague and tularemia, respectively). The development of plazomicin is supported by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services.
Achaogen is a biopharmaceutical company dedicated to discovering, developing, and commercializing treatments for serious infections caused by MDR gram-negative bacteria.