EISAI ANNOUNCES RESULTS OF SEPSIS TRIAL
Tokyo-based Eisai, along with U.S.-based Eisai Medical Research, will initiate a Phase III clinical program for eritoran as a potential treatment for severe sepsis. Eisai's decision is based on Phase II study results that showed a reduction in mortality in eritoran-treated patients versus placebo.
The Phase II study, conducted in North America, involved 293 patients randomized to three groups: eritoran high dose, eritoran low dose 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 percent compared to placebo. The study was not sized to detect a statistically significant difference in mortality. The mortality in the high-dose group was reduced by 6.4 percent compared to placebo. Mortality was 33.3 percent in placebo, 32.0 percent in the low-dose group and 26.9 percent in the high-dose group.