On December 12, 2016, Achaogen, Inc.(NASDAQ:AKAO) 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). In addition, 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 of the few remaining antibiotics for treatment of infections due to CRE.
Achaogen has jumped from $5.25 to $13.03, up 148.19% on the day.
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. It was incorporated in Delaware in 2002 and commenced operations in 2004. Additional information on the Company can be found at www.achaogen.com.
About the EPIC Trial
EPIC (Evaluating plazomicin in cUTI) was a multinational, randomized, controlled, double-blind clinical trial in adult patients with cUTI and AP. The trial enrolled 609 patients who were randomized 1:1 to receive plazomicin 15 mg/kg as a once daily 30-minute intravenous (IV) infusion or meropenem 1.0 gram every 8 hours as a 30 minute IV infusion. After a minimum of 4 days of IV therapy, patients who met protocol-defined criteria for improvement were allowed to step-down to oral levofloxacin to complete a total of 7 to 10 days of therapy (IV plus oral).
About the CARE Trial
CARE (Combating Antibiotic Resistant Enterobacteriaceae) was a multinational, open label, Phase 3 clinical trial evaluating the efficacy and safety of plazomicin in patients with serious bacterial infections due to CRE. The study included two cohorts of patients. Cohort 1 (N=39) was a randomized, comparator-controlled cohort to compare plazomicin with colistin (either in combination with meropenem or tigecycline) for the treatment of bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP) or ventilator associated bacterial pneumonia (VABP) due to CRE. Cohort 1 enrolled 30 patients with BSI and 9 patients with HABP/VABP. Cohort 2 (N=30) was a single-arm expanded access cohort to evaluate plazomicin-based therapy in patients with BSI, HABP/VABP or cUTI due to CRE who were not eligible for enrollment in Cohort 1.