XOMA completes patient enrollment in XOMA 052 Phase 2a trial

Sep 29 2010

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that patient enrollment was recently completed for the company's Phase 2a trial of XOMA 052 in patients with Type 2 diabetes. XOMA 052 is a therapeutic antibody candidate that inhibits the inflammatory cytokine interleukin-1 beta (IL-1 beta) that may be a major cause of diabetes and cardiovascular disease. The Phase 2a trial follows the completion of positive Phase 1 trials in Type 2 diabetes patients and is designed to gain additional information on XOMA 052's anti-diabetes activity including glycosylated hemoglobin (HbA1c) levels, impact on biomarkers of cardiovascular risk, and safety. XOMA anticipates reporting top line results in early January 2011 from a planned interim analysis of the first three months of treatment in this six month trial.

In the trial, 74 patients were enrolled and randomized in a 3:1 ratio to receive three months of treatment with either XOMA 052 at a single dose level or placebo, respectively, along with metformin, the standard of care. After three months, patients in the active treatment arm are treated for an additional three months at either the same, a higher or a lower dose of XOMA 052. Patients in the placebo group also were continued for an additional three months. In addition to HbA1c, outcomes to be evaluated include fasting blood glucose and levels of C-reactive protein, a biomarker of cardiovascular risk. Further information is available at>

XOMA has also completed enrollment in a larger Phase 2b trial of XOMA 052 in patients with Type 2 diabetes. Top line results from this dose-ranging trial, in which 420 patients were enrolled, are expected to be available in the first quarter of 2011. Patients on metformin therapy were randomized equally to one of four XOMA 052 dose groups or placebo for monthly treatments over six months. The primary outcome to be evaluated in this trial is mean change in HbA1c from baseline at the end of treatment. Additional diabetic outcomes as well as inflammatory and cardiovascular disease biomarkers will be evaluated. Further information is available at>

The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes patients in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently.

"The completion of enrollment in the Phase 2 studies of XOMA 052 is an important step forward for XOMA in our efforts to develop a potentially disease-modifying medicine for Type 2 diabetes and other chronic indications," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "XOMA 052 is designed to treat the inflammatory cause of diabetes and other difficult diseases. It has the potential to provide patients an entirely new approach to controlling their disease."