US-based biopharmaceutical company Achaogen has reported positive results from its Phase III EPIC registration trial and Phase III CARE trial of plazomicin to treat patients with complicated urinary tract infections (cUTI) and carbapenem-resistant Enterobacteriaceae (CRE) infections.
Plazomicin is a aminoglycoside, synthetically derived from sisomicin by appending a hydroxy-aminobutyric acid substituent at position one and a hydroxyethyl substituent at position six.
It has been developed to prevent bacterial protein synthesis and demonstrate dose-dependent bactericidal activity.
The evaluating plazomicin in cUTI (EPIC) trial has been conducted as a multinational, randomised, controlled, double-blind clinical study, which treated 609 patients with cUTI and acute pyelonephritis (AP).
During the trial, the patients were randomised to receive plazomicin through a 30-minute intravenous (IV) infusion on a once-daily basis or meropenem every eight hours as a 30 minute IV infusion.
Results suggested plazomicin meeting the US Food and Drug Administration (FDA) specified primary efficacy endpoint to establish its non-inferiority compared to meropenem and achieving superiority as per European Medicines Agency (EMA) specified primary efficacy endpoint.
The Combating Antibiotic Resistant Enterobacteriaceae (CARE) multinational, open-label clinical trial was intended to determine the efficacy and safety of plazomicin in patients with serious bacterial infections due to CRE.
The trial included 39 patients in its first randomised, comparator-controlled cohort to compare plazomicin with colistin to treat bloodstream infection (BSI), hospital-acquired bacterial pneumonia (HABP) or ventilator associated bacterial pneumonia (VABP) due to CRE.
In the second cohort, 30 patients with BSI, HABP / VABP or cUTI due to CRE were enrolled and treated with plazomicin compared with colistin therapy.
Primary analysis of Cohort 1 suggested plazomicin resulting in a lower rate of mortality or serious disease-related complications than colistin therapy.
Achaogen CEO Kenneth Hillan said: "We are thrilled with the outcome of both the EPIC and CARE clinical trials and the potential opportunity for plazomicin to address many of the multi-drug resistant bacterial infections occurring every day.
"We are grateful to the patients and investigators who were involved in both of these studies, and we look forward to seeking plazomicin's approval from FDA and EMA. We believe that, if approved, plazomicin will provide an important new option in treating MDR infections, including those caused by CRE."
The company plans to submit a new drug application (NDA) to the FDA based on data from both EPIC and CARE trials during the second half of next year.
In 2018, the company also intends to submit a marketing authorisation application (MAA) to the EMA.
Additionally, the company plans to report detailed results from both the EPIC and CARE trials in 2017.