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news.Achaogen (AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, has announced that the first patient has been enrolled in a Phase 3 clinical trial of plazomicin to treat infections caused by carbapenem-resistant Enterobacteriaceae (CRE).
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The Phase 3 clinical trial is designed to demonstrate the superiority, in terms of mortality at 28 days, of a plazomicin-based regimen compared with a colistin-based regimen in the treatment of patients with bloodstream infections or nosocomial pneumonia due to CRE.
As previously reported by Achaogen, the trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority (BARDA) for up to $103.8 million.
"Commencing enrollment into this Phase 3 clinical trial of plazomicin is a significant accomplishment as hospital based CRE infections pose a serious health threat globally," said Kenneth J. Hillan, Chief Executive Officer of Achaogen.
"We have initiated sites in the U.S. and Europe, and will further expand to sites in other important geographic regions in the coming months. The clinical advancement of plazomicin moves Achaogen closer to reaching our goal of providing effective new treatments to patients with life threatening gram-negative infections, such as CRE."
The need for new antibiotics to treat CRE is particularly acute, as these bacteria are commonly multi-drug resistant — that is, they are insensitive to nearly all antibiotics commonly used to treat gram-negative infections, including carbapenems, cephalosporins, beta-lactam/beta-lactamase inhibitor combinations, fluoroquinolones, and currently-marketed aminoglycosides.
Resistance to carbapenems has been highlighted as a particular concern because carbapenems are one of the last lines of defense against antibiotic-resistant gram-negative infections. Most CRE express enzymes called carbapenemases, which break down the carbapenem antibiotic molecule before it can kill the bacteria.
Due to the lack of effective therapies, CRE infections are associated with significant mortality, with up to 50% mortality observed in patients with bloodstream infections.