XOMA initiates Phase 2 clinical trial of XOMA 052 in Type 1 diabetes patients

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the initiation of a Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. XOMA is the study sponsor and will provide XOMA 052 drug product for the trial.

The trial is designed to evaluate the effects of an anti-inflammatory treatment approach in Type 1 diabetes patients. The randomized, placebo-controlled study in 24 patients with well-controlled Type 1 diabetes 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. Dr. Marc Donath, Professor of Endocrinology and Diabetes at the University Hospital of Zurich, pioneer in anti-inflammatory approaches to diabetes treatment, and a principal investigator in the Phase 1 studies of XOMA 052, is principal investigator for the trial.

"The study is based on the recent observations of ongoing destruction of the insulin producing beta-cells even after decades of disease duration," said Dr. Donath. "Protecting the cells with XOMA 052 may allow for beta-cell regeneration in Type 1 diabetes patients."

"We are pleased that patient enrollment has begun in this trial in Type 1 diabetes patients while XOMA continues to advance studies of XOMA 052 in patients with Type 2 diabetes and cardiovascular disease," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer.  "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 of anti-inflammatory therapy that could lead to improvement in diabetes patients' lives."

According to the JDRF, as many as 3 million Americans may have Type 1 diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the patient's own immune system destroys the patient's beta cells in their pancreas that normally control blood sugar level. Patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump every day for the rest of their lives. And even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation. 

IL-1 beta has been demonstrated to be involved in the destruction of pancreatic beta cells in patients with Type 1 diabetes as well as Type 2 disease.  In Type 1 diabetes, immune cells that target a patient's pancreatic beta cells initiate the damage, which results in an increase in blood glucose levels. The higher blood glucose levels stimulate the production of the pro-inflammatory cytokine IL-1 beta which, in turn, feeds back on the pancreatic beta cells, reducing their insulin-production efficiency and eventually leading to cell death. XOMA 052 is an antibody that binds to IL-1 beta and interferes with the activation of the IL-1 receptor, thereby reducing cellular signaling events that produce pathological levels of inflammation.