(Reuters) - Achaogen Inc said its lead experimental drug, plazomicin, was as effective as the broad spectrum antibiotic, meropenem, in the phase 3 EPIC trial involving patients with complicated urinary tract infections and acute pyelonephritis.
A complicated urinary tract infection is associated with an underlying condition, which increases the risk of failing antibacterial therapy. Pyelonephritis typically occurs when bacteria migrate from the bladder to the kidney, infecting the organ.
In a separate phase 3 study known as CARE involving patients with serious infections due to carbapenem-resistant enterobacteriaceae (CRE), plazomicin showed a lower rate of mortality or serious complications compared with colistin therapy, one of the few remaining antibiotics used to treat CRE.
"We are thrilled with the outcome of both the EPIC and CARE clinical trials and the potential opportunity for plazomicin to address many of the multi-drug resistant bacterial infections occurring every day," Kenneth Hillan, Achaogen's Chief Executive Officer, said in a press release. (http://bit.ly/2hpoRM9)
"We are grateful to the patients and investigators who were involved in both of these studies, and we look forward to seeking plazomicin's approval from FDA and EMA. We believe that, if approved, plazomicin will provide an important new option in treating MDR infections, including those caused by CRE," he added.
Achaogen's shares were halted in premarket trading.