Eisai Phase III Study Does Not Meet Primary Endpoint
News Jan 27, 2011
The decision was based on the fact that the study did not meet its primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis.
Eisai will continue an analysis of the data and determine next steps. Eisai remains committed to addressing critical areas of unmet need, such as sepsis.
The ACCESS trial was a global, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of eritoran as a potential treatment for severe sepsis. The population studied had a moderate-to-high risk of mortality as determined by baseline APACHE II (Acute Physiology and Chronic Health Evaluation II) scores from 21 to 37. APACHE II is a severity of illness scoring system commonly used in sepsis research. This scoring system and other severity of illness scoring systems are also used in intensive care units (ICU).