-- EPIC registration trial successfully achieves FDA primary endpoints in patients with complicated urinary tract infections (cUTI) --

-- EPIC demonstrates superiority on EMA primary endpoints --

-- CARE descriptive trial shows 71 percent relative reduction in Day 28 all-cause mortality compared with colistin in patients with serious CRE infections --

-- Plazomicin well tolerated in both trials and shows improved overall safety compared with colistin in CARE trial --

-- Company plans to proceed with regulatory submissions in the U.S. and Europe --

-- Company to host a conference call and webcast today at 8:30 a.m. EST --

 

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2016 -- Achaogen, Inc. (NASDAQ:AKAO), 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).