Eli Lilly has ended a clinical trial of its sepsis treatment Xigris in children after an interim analysis said the drug would be unlikely to show a benefit over placebo.
According to a letter posted on the product’s website, an independent safety panel also observed a higher rate of central nervous system bleeding amongst patients given Xigris. During the first six days of the study – the infusion period – four children in the Xigris group suffered a brain haemorrhage compared to just one amongst placebo receivers. And, over the entire 28-day study period, this rose to eight and five in the Xigris and placebo groups respectively. Full results will become available later on in the year and will be presented at a medical meeting, says the firm.
However, the news barely shifted the company’s share price as investors have long got used to the fact that Xigris is unlikely to become a big earner for Lilly. Earlier this week, its use was restricted in Europe after data showing an increased mortality rate in clinical trials of patients with single organ dysfunction who had recently undergone surgery [[25/04/05c]].