Sepsis rewards being first

While Eli Lilly and Co. is setting standards for sepsis trial design and patient selection by being the first company to show a reduction in 28-day all cause mortality in a pivotal trial, its success may further complicate the field for other sepsis players.

Sepsis has long been a daunting indication for pharmaceutical and biotech companies, largely because it is a complex syndrome associated with many underlying disorders. Due to the 28-day mortality endpoint the FDA has chosen to accept for sepsis trials, one major challenge lies in selecting a patient population in which the underlying disease pathology does not confound detection of a study drug effect. ...