The investigational compound, eritoran tetrasodium (eritoran, also known as E5564) appeared to be well tolerated in patients with severe sepsis in a phase-II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.
The trial evaluated two doses of eritoran, low-dose (45mg given every 12 hours for six days) and high-dose (105mg given every 12 hours for six days), along with a placebo group. Additionally, the trial, although not powered for statistical significance, evaluated the efficacy (reduction in 28-day all-cause mortality) of eritoran versus placebo.
"Currently, limited treatment options exist for severe sepsis. In this phase-II study, eritoran was well tolerated, and the adverse events were not surprising, given the significant co-morbidities commonly seen in patients with severe sepsis," said lead investigator Mark Tidswell, director, ICU Research, Baystate Medical Center, Adult Critical Care Division, in Springfield, Mass. "Although this phase-II trial was not sized to demonstrate a reduction in mortality and the observed 26.6 per cent mortality rate for high-dose eritoran versus 33.3 per cent for placebo (p=0.34) was not statistically significant, the data warrant further investigation of eritoran."
Based on the trial results, Eisai is now conducting a global phase-III clinical trial program, called ACCESS (A Controlled Comparison of Eritoran tetrasodium and Placebo in Patients with Severe Sepsis).
Sepsis is a condition involving infection and inflammation. The body's normal response to an infection is to initiate an immunological chain reaction of inflammation.
Eisai Inc was established in 1995 and is ranked among the top-20 US pharmaceutical companies (based on retail sales).