The phase II study results that showed a reduction in mortality in eritoran-treated patients versus placebo. The company plans to initiate a phase III clinical program after consulting with regulatory authorities in the US, Canada and European Union.
The study, conducted in North America, involved 293 patients randomized to three groups, eritoran high dose (105mg/6days), eritoran low dose (45mg/6days) and placebo. Eritoran was administered twice daily by intravenous infusion. The goal of the study was to test whether eritoran could reduce the 28-day all-cause mortality by at least 5% compared to placebo. The study was not sized to detect a statistically significant difference in mortality.
The drug appeared to be well tolerated. Phlebitis, or inflammation of the vein, was observed in some patients dosed with eritoran through a peripheral vein. It showed a tendency to recover with time.
During sepsis, the body’s normal response is to set off a limited chain reaction to fight the infection. In severe sepsis, this systemic response escalates into an overreaction by the body that leads to organ failure and may become life-threatening.