A Chiron drug that failed as a treatment for sepsis took a step closer to finding a use in severe community-acquired pneumonia, after no safety issues emerged in an interim analysis of a Phase III trial.
The data monitoring committee overseeing the trial of tifacogin, a recombinant tissue factor pathway inhibitor (TFPI), said the study should continue as planned as no untoward side effects had been encountered.
Severe CAP is pneumonia contracted outside of a hospital setting that requires admission to an intensive therapy unit. It affects around 300,000 people in the USA every year, and a third of them die. Current therapy includes routine antibiotics and supportive care, but despite improvements in treatment, mortality rates associated with severe CAP have remained largely constant for the past 50 years.
If approved, tifacogin could be the first adjunctive drugs to become available for the reduction of mortality in severe CAP.
The trial, called CAPTIVATE, is expected to enroll 2,100 patients by the first half of 2007. The primary endpoint of the study is reduction in mortality at 28 days.