Achaogen has announced positive results from the Phase 3 trials (‘EPIC’ and ‘CARE’) of plazomicin, a lead candidate for potential treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).
Plazomicin is being investigated in the treatment of gram-negative infections. The EPIC double-blind trial enrolled 609 patients with cUTI and AP, while the CARE open-label trial enrolled 69 patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae.
Participants in the EPIC trial were randomized 1:1 to receive plazomicin 15mg/kg as a once daily 30-minute intravenous (IV) infusion or meropenem 1g every 8 hours as a 30 minute IV infusion.
At day 5 of treatment, plazomicin treatment showed statistical non-inferiority to meropenem, with 88% of plazomicin treated patients reaching clinical cure vs. 91.4% in the meropenem treated group (difference –3.4%, 95% CI: –10.0, 3.1%). Microbiological eradication at the test-of-cure visit was 81.7% in the plazomicin group vs. 70.1% in the meropenem group (difference 11.6%, 95% CI: 2.7, 20.3%), indicating statistical superiority.
The CARE trial compared plazomicin with colistin (either in combination with meropenem or tigecycline) for all-cause mortality at Day 28 or significant disease related complications. At Day 28, the plazomicin group had a rate of 23.5% and 11.8% for all-cause mortality or significant disease-related complications and all-cause mortality, respectively. In comparison, the corresponding rates for the colistin group were 50% and 40%, respectively. However, due to the small sample size, no statistical hypothesis was performed.
Based on the results from EPIC and CARE, Achaogen plan to submit a New Drug Application (NDA) to the FDA in the second half of 2017. “We look forward to seeking plazomicin’s approval from FDA,” said Kenneth Hillan, MB, ChB, and Achaogen’s CEO.
“Plazomicin’s superiority in microbiologic cure for patients with cUTI at the test-of-cure visit compared to meropenem, a gold standard for treating multi-drug resistant infections, is impressive,” said James A. McKinnell, Assistant Professor of Medicine at the David Geffen School of Medicine.
For more information visit achaogen.com.