Firm has to ditch original plans for regulatory filing of drug by end of March.
Eisai has confirmed that the failure of a Phase III trial evaluating its severe sepsis candidate eritoran (E5564) means it will not be able to file for regulatory approval of the drug in the U.S., Europe, and Japan by the end of March, as originally planned.
The reported Phase III global ACCESS study evaluated the safety and efficacy of eritoran in the treatment of severe sepsis in patients with a moderate-to-high risk of mortality as assessed by baseline APACHE II (Acute Physiology and Chronic Health Evaluation II) scores. Eisai has not detailed full results data from the trial, but the firm does say that it did not meet its primary endpoint of reduction in 28-day all-cause mortality.
The firm notes that it will decide on the future of its eritoran development program alongside further analysis of the ACCESS study data. Data from a previous dose-ascending Phase II study with eritoran was reported back in 2009. The trial was not big enough to evaluate a reduction in mortality, but at the time the firm said the observed 26.6% mortality rate for high-dose eritoran versus 33.3% for placebo did warrant further investigation.