XOMA To Initiate Phase 2 Clinical Trial Of XOMA 052

XOMA seeks to initiate an investigator sponsored phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. The trial will be sponsored by the Juvenile Diabetes Research Foundation International (JDRF).

The company said that the study is designed to evaluate the effect of anti-inflammatory treatment in type 1 diabetes patients after the initial period of autoimmune activity that results in the loss of blood sugar level control, attempting to prevent the complete loss of beta cells. It follows an initial study indicating that anti-IL-1 drugs may have positive benefit for patients with type 1 diabetes.

According to XOMA, the randomized, placebo-controlled study in 24 patients with well-controlled type 1 diabetes (who have had the disease for at least two years), will measure the effects of treatment with XOMA 052 over six months on beta cell function and insulin production. The safety, tolerability, and pharmacokinetics of XOMA 052 will also be assessed.

Reportedly, XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds to Il-1 beta, a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.

Steven Engle, chairman and CEO of XOMA, said: “The evaluation of our general anti-inflammatory drug candidate, XOMA 052, in multiple diseases continues to expand. We are pleased that Dr. Donath plans to initiate a study in Type 1 diabetes with JDRF support.

“In parallel, XOMA continues to focus on conducting studies of XOMA 052 in patients with Type 2 diabetes and cardiovascular disease. If successful, this study would be the first showing the impact of reducing inflammation in Type 1 diabetes patients with disease duration of two years or more. It would provide additional evidence of the benefit anti-inflammatory therapy that could lead to the improvement in the lives of many patients.”

Earlier this year, XOMA completed successful phase 1 trials of XOMA 052 in Type 2 diabetes patients. The company initiated its phase 2 program in type 2 diabetes and cardiovascular disease this quarter.