Achaogen, Inc. announced the enrollment of its first patient in EPIC (Evaluating plazomicin in cUTI), a Phase 3 clinical trial of plazomicin to treat complicated urinary tract infections (cUTI) including acute pyelonephritis (AP). Achaogen also announced the enrollment of patients in the second cohort of its Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) study, including a patient enrolled with cUTI caused by carbapenem-resistant Enterobacteriaceae (CRE). EPIC is a multi-national, randomized, controlled, double-blind study which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections of the urinary tract.

EPIC is intended to serve as a single pivotal trial supporting a new drug application (NDA) for plazomicin in the United States. The company remains on track to release top-line results from EPIC and submit an NDA in the second half of 2017. The CARE study, initiated in 2014, is a Phase 3 randomized controlled study of plazomicin in the treatment of patients with bloodstream infections (BSI) or pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE).

A second protocol amendment (AM2) added a second single-arm cohort (Cohort 2) to the trial enabling enrollment of patients with confirmed CRE who are not eligible for the randomized study arms (Cohort 1). The Company expects Cohort 2 will generate important additional clinical data for plazomicin in the treatment of a wide range of patients with CRE infections, including cUTI, a patient population representing a significant unmet medical need.