Achaogen Announces Enrollment of First Patient in EPIC, a Phase 3 Clinical Trial for the Treatment of Complicated Urinary Tract Infections (cUTI) With PlazomicinJanuary 11, 2016
SOUTH SAN FRANCISCO, CA, USA I January 11, 2016 I Achaogen, Inc. (AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, announced today 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 today 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.
“MDR gram-negative infections are a significant and increasing problem. We need new antimicrobials for treatment as the current armamentarium is sparse and/or toxic,” said Ravi Kamepalli, MD, Regional Infectious Diseases and Infusion Center (RIDIC) in Lima, OH. “The EPIC trial will enable us to assess plazomicin’s efficacy and safety in patients with complicated UTI and evaluate its potential to significantly advance the field.”
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.
“Enrolling the first patients into EPIC and CARE Cohort 2 is an exciting milestone in our development program for plazomicin,” said Kenneth Hillan, Achaogen’s Chief Executive Officer. “The EPIC study is an integral part of our strategy to expedite the path to market for plazomicin, and Cohort 2 of the CARE study is reflective of our ongoing commitment to generate important clinical data for plazomicin in the treatment of patients with CRE infections who are desperately in need of new therapeutic options.”
Plazomicin is a novel aminoglycoside antibiotic that Achaogen engineered to overcome key aminoglycoside resistance mechanisms. It is being developed for the treatment of bacterial infections due to Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae, or CRE. Plazomicin remains active against most MDR Enterobacteriaceae, including CRE, where most other antibiotics, have limited potency due to resistance. The development of plazomicin is supported by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious urinary tract, lung, and bloodstream infections due to Enterobacteriaceae, including CRE. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com<http://www.achaogen.com>.