FDAnews
www.fdanews.com/articles/73245-il-1-trap-shows-positive-results-in-patients-with-inflammatory-disease

IL-1 Trap Shows Positive Results in Patients With Inflammatory Disease

June 10, 2005

Regeneron Pharmaceuticals has announced positive preliminary results from an ongoing pilot study of once-weekly dosing of the Interleukin-1 (IL-1) Trap in patients with CIAS1-associated periodic syndrome (CAPS), a family of autoinflammatory diseases.

All four patients enrolled in the study to date experienced a positive response to a subcutaneous loading dose regimen of the IL-1 Trap, including a sizable reduction in daily patient diary scores and acute phase reactant levels. In the ongoing chronic dosing phase of the study, these patients continue to demonstrate a positive response to the IL-1 Trap.

The study was conducted under a cooperative research and development agreement with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the NIH. The FDA has granted orphan-drug designation to the IL-1 Trap in CAPS disorders. Currently, there are no approved therapies for CAPS disorders, the company said.