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news.Demonstrated eritoran to be well tolerated in patients with severe sepsis
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Eisai has presented results of the investigational compound, eritoran tetrasodium (E5564), where it 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 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, said the company.
The trial of eritoran tetrasodium (E5564) was a phase II, randomized, double-blind, placebo-controlled, multi-center, ascending-dose trial evaluating the safety and efficacy of eritoran in patients with severe sepsis.
The trial, conducted in intensive care units (ICUs) in the US and Canada, involved 300 patients randomized to three groups as 96 received placebo, 103 received eritoran low-dose (45mg given every 12 hours for six days) and 94 patients received eritoran high-dose (105mg given every 12 hours for six days).
Seven patients did not receive any trial drug and were not included in the modified intent to treat population for analysis. Eritoran or placebo doses were administered via intravenous infusion within 12 hours of recognition of severe sepsis and repeated every 12 hours for six days.
In this phase II trial, eritoran was well tolerated and some adverse events like anemia, diarrhea, insomnia, acute renal failure and rash were observed more frequently in the group receiving eritoran compared to the group receiving placebo, although not statistically significant, said the company.
The greatest benefit was observed in the population at the highest risk of mortality as assessed by APACHE II Predicted Risk of Mortality (PROM). In patients who were considered at higher risk of death, mortality among placebo patients was 56.3% versus 33.3% in high-dose patients (p=0.105).