Achaogen Inc (NASDAQ:AKAO), a clinical-stage biopharmaceutical firm advancing unique antibacterial addressing MDR gram-negative infections reported that its lead candidate, plazomicin, met the goal of non-inferiority versus meropenem for the U.S. FDA and recorded superiority for the EMA primary efficacy objectives in the Phase III EPIC registration study in subjects with complicated urinary tract infections and acute pyelonephritis.
In addition, in the Phase III CARE study in subjects with serious infections due to CRE a lower rate of mortality or grave disease-related complications was seen for plazomicin as against colistin treatment, one of the few antibiotics for infections treatment due to CRE.
The management speaks
Kenneth Hillan, M.B. Ch.B., the CEO of Achaogen, said that they are excited with the outcome of both the CARE and EPIC clinical studies and the potential prospect for plazomicin to address numerous multi-drug resistant bacterial infections noted every day. They are grateful to the investigators and patients who were involved in these trials, and they look forward to getting plazomicin’s approval from EMA and FDA. They consider that, if accepted, plazomicin will offer an important new alternative in treating MDR infections, comprising those caused by CRE.
Achaogen intends to file a New Drug Application, which will include CARE and EPIC data, to the FDA in 2H2017. The firm also plans to file a Marketing Authorization Application to the EMA in 2018. Additionally, Achaogen intends to publicly present detailed report from both the CARE and EPIC trials in 2017.
These data are better and exceptional than the company would have anticipated, plazomicin’s superiority in microbiologic treatment for subjects with cUTI at the test-of-cure visit against meropenem is remarkable. Importantly, the safety profile of this medication looks favorable. The results from the CARE study offers compelling evidence for plazomicin as a cure option for grave infections due to CRE. The sample size for the CARE trial was small, but the results represented an evident trend in favor of plazomicin in aspect of efficacy and overall safety as against colistin.