Achaogen's Patient Enrollment in Final Stage EPIC Registration Trial of Plazomicin Reaches 50%

Achaogen, Inc.

disclosed that it achieved more than 50 percent patient enrollment in its ongoing final stage EPIC registration clinical trial of plazomicin. According to the company, Achaogen is developing plazomicin, its lead product candidate, to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Achaogen's CEO, Kenneth Hillan, commented, "Enrollment in the EPIC clinical trial has been progressing well and we are pleased that we have enrolled half of the approximately 530 patients that we intend to recruit for the trial. We look forward to completing enrollment in the EPIC trial this year and expect to report top-line data in first quarter of 2017." The company also said that EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI). This included acute pyelonephritis (AP), which was expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections. Achaogen indicated that the EPIC trial was expected to serve as a single pivotal trial and support a New Drug Application (NDA) submission in the second half of 2017. The Company also expects to announce top-line results for the CARE study in the first half of 2017. Following the news, the stock advanced 8.9 percent in the pre-market trading on Thursday.