Achaogen passes US and European hurdles to market its plazomicin antibiotic

Achaogen’s multi-drug resistant (MDR) gram-negative product antibiotic candidate, plazomicin, met the objective  for the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

It has meet primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

Achaogen said on Monday that 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 antibiotic of the few remaining, 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 said it 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.

James A. McKinnell, Assistant Professor of Medicine at UCLA, said that theantibiotic test exceeded his expectations. He added: “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