The phase III program of the Interleukin-1 (IL-1) Trap included two studies. Both studies met their primary endpoints, which was a reduction in disease activity. The activity was measured using a composite symptom score composed of a daily evaluation of fever/chills, rash, fatigue, joint pain, and eye redness/pain. The first study had an approximately 85% reduction in their mean symptom score compared to an approximately 13% reduction in patients treated with placebo.
Regeneron plans to file a biologics license application with the FDA in the second quarter of 2007. The FDA has granted orphan drug status and fast track designation to the IL-1 Trap program.
“Many of my CAPS patients who participated in the trial described dramatic responses to this investigational therapy,” said Hal Hoffman, associate professor of Pediatrics and Medicine at the University of California.