Eli Lilly is planning to conduct a clinical trial of its Xigris sepsis drug alongside a diagnostic biomarker in a bid to kickstart use of the product.
Xigris (drotrecogin alfa) remains the only drug that has been approved for sepsis, despite decades of research and dozens of clinical candidates, but has failed to live up to its once-touted blockbuster potential. It is reserved for only the sickest patients, and last year brought in sales of just $214 million, a rise of just 6% over 2004.
The primary problem with Xigris is that it is difficult to know which patients stand to gain the most clinical benefit from the drug. Lilly has signed an agreement with Biosite to develop the biomarker for use as a screening test both for admission into its Phase IIb trial, called RESPOND, along with other already-used protein C diagnostics.
Biosite will develop the point-of-care test, which will measure protein C levels and could eventually to select patients for treatment and monitor their response to treatment. Xigris itself is a recombinant form of activated protein C.
“We hope this biomarker strategy will help maximise the value of this medicine for critically ill sepsis patients,” commented John Lechleiter, Lilly’s president and chief operating officer.
Severe sepsis causes about 215,000 deaths in the USA each year. It often develops as a complication after common illnesses such as pneumonia, and bacterial infections.