Monday, July 3, 2000
The gold standard for sepsis treatments is 28-day all-cause mortality in a Phase III study, an end point that has dashed the dreams of companies and investors for the better part of a decade. Eli Lilly and Co., which has finally beaten the odds, believes that it avoided adding its name to the sepsis tombstone because its Zovant recombinant human activated protein C has multiple mechanisms of action, thus covering three bases in the multi-causal indication.
LLY last week halted recruitment in its placebo-controlled Phase III Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial of Zovant to treat severe sepsis after a favorable recommendation from a Data and Safety Monitoring Board. The board's interim analysis of 1,520 patients showed that the primary end point of 28-day, all-cause mortality had been met.