Eisai has reported that eritoran, its potential treatment for severe sepsis, has failed to meet the primary endpoint of a Phase III trial.
The company has decided not to submit marketing authorisation applications to regulatory authorities in the US, EU and Japan by the end of the fiscal year as previously planned.
The global, randomised, double-blind, placebo-controlled trial evaluated a population that had a moderate-to-high risk of mortality as determined by baseline APACHE II scores (21 to 37).
Preliminary findings indicated that the drug did not meet the primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis.
Severe sepsis causes approximately 215,000 deaths in the US every year, with a mortality rate of approximately 30%. It is estimated to affects 18 million people worldwide every year.
