This orphan drug program is assessing the efficacy and safety of the company’s Interleukin-1 (IL-1) trap in adult patients with these diseases.
The trial will include a six-month, placebo-controlled efficacy phase and be followed by a six-month, open label extension phase, which will help to characterize the safety of the IL-1 trap. The efficacy phase of this trial is expected to be completed by the end of 2006.
“Treatment with the IL-1 trap in the phase II study led to immediate and sustained improvements in CAPS patients as assessed by both clinical and laboratory measurements. We are hoping the encouraging results we saw in the phase II study will be replicated in this larger trial. The information we derive from this trial will be critical to evaluating the IL-1 trap in other serious inflammatory conditions in which IL-1 may be a key factor,” said George Yancopoulos, Regeneron’s executive vice president and chief scientific officer.