Achaogen, Inc., a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that its lead product candidate, plazomicin, met the objective of non-inferiority compared to meropenem for the U.S. Food and Drug Administration (FDA) and achieved superiority for the European Medicines Agency (EMA) primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

carbapenem-resistant Klebsiella pneumoniae (CRKP) /CDC
carbapenem-resistant Klebsiella pneumoniae (CRKP) /CDC

In addition, in the Phase 3 CARE trial in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to 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,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “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.”

Achaogen plans to submit a New Drug Application (NDA), which will include EPIC and CARE data, to the FDA in the second half of 2017. The Company also plans to submit a Marketing Authorization Application (MAA) to the EMA in 2018. In addition, Achaogen plans to publicly present detailed results from both the EPIC and CARE trials in 2017.

“These data are exceptional and better than I would have expected – plazomicin’s superiority in microbiologic cure for patients with cUTI at the test-of-cure visit compared to meropenem, a gold standard for treating MDR infections, is impressive. Importantly, the safety profile of the drug looks favorable,” said James A. McKinnell, Assistant Professor of Medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA. “The data from the CARE trial provides compelling evidence for plazomicin as a treatment option for serious infections due to CRE. The sample size for the CARE study was small, but the data show a clear trend in favor of plazomicin in terms of efficacy and overall safety compared to colistin. CRE infections cause serious morbidity and mortality and seem to be on the rise. Based on these data, plazomicin would be a valuable addition to my short list of available treatment options for both empiric and directed treatment of patients, and as a single agent or in combination with other antibiotics.”

In the EPIC trial, plazomicin successfully met the objective of non-inferiority compared to meropenem for the FDA-specified primary efficacy endpoints, and achieved superiority for the EMA-specified primary efficacy endpoints.