Achaogen Inc.'s lead product plazomicin achieved U.S. FDA primary endpoints in patients with complicated urinary tract infections and acute pyelonephritis, compared to meropenem.
Plazomicin is being developed to treat serious bacterial infections due to multidrug-resistant enterobacteriaceae. The drug also demonstrated superiority for the European Medicines Agency-specified primary efficacy endpoints in the phase 3 EPIC registration trial in patients with cUTI.
In addition, plazomicin performed well in the phase 3 CARE trial in patients with serious infections due to carbapenem-resistant enterobacteriaceae, an antibiotic resistant bacteria, showing a 71% relative reduction in mortality compared with therapy with antibiotic colistin.
The company plans to submit a new drug application to the FDA in the second half of 2017 and a marketing authorization application to the EMA in 2018.