Cortech Sepsis Drug Joins Failure List

It looks increasingly like the pharmaceutical industry is going to be unable to make any sort of advance in the care of sepsis patients, as the catalogue of failed products expands almost by the week. It was Synergen's turn last week, with the news that its Antril (anakinra) candidate was unable to confer a benefit on mortality; this week Cortech's bradykinin antagonist Bradycor appears to have gone the same way.

A preliminary analysis of Cortech's Phase II study of Bradycor in patients with systemic inflammatory response syndrome and presumed sepsis has not demonstrated a clinically meaningful reduction in risk-adjusted 28-day survival. The trial involved 500 patients at 47 sites. Based on these results, Cortech says it does not expect to start a pivotal efficacy trial in sepsis in the near future, mainly because any trends observed in the Phase II study were not of sufficient magnitude to allow for the design of a Phase III trial. More detailed results from the SIRS trial will be presented on August 1 at the Peptides and their Antagonists in Tissue Injury conference in Montreal. It may be that, learning from Synergen's mistakes, Cortech will be reluctant to continue development of Bradycor in sepsis without entering into a corporate collaboration to spread costs.

Further development of Bradycor in sepsis will depend upon additional analyses of the three-day infusion study and evaluation of an ongoing Phase II study in which a seven-day infusion is being used, said Tim Rodell, executive vice president of operations and product development at Cortech.