XOMA Ltd. announced that its phase 2b trial of XOMA 052 in type 2 diabetes patients did not achieve the primary endpoint of reduction of HbA1c after six monthly treatments with XOMA 052 compared to placebo.
Biological activity of XOMA 052 supporting its potential in cardiovascular disease was observed with highly significant decreases in C-reactive protein, or CRP, a biomarker for the risk of heart attack, stroke and other cardiovascular diseases in all dose groups versus placebo.
In addition, statistically significant improvements in high-density lipoprotein, or “good” cholesterol were observed in two of four XOMA 052 dose groups versus placebo. XOMA 052 was well-tolerated in this trial, with no serious drug-related adverse events and a safety profile consistent with previous trials.
The randomized, placebo-controlled dose-ranging phase 2b trial enrolled 421 patients at multiple sites in the United States during 2010. Eligible patients had type 2 diabetes and were receiving metformin monotherapy, the standard of care for initial treatment of diabetes. Patients were randomized to receive one of four XOMA 052 doses or placebo monthly over six months via subcutaneous administration. The primary endpoint of the study was the change in HbA1c levels from baseline compared to placebo at six months.
Baseline characteristics were similar between the XOMA 052 and placebo groups. At study entry, the mean CRP was 4.8 mg/L and 4.2 mg/L in the XOMA 052 and placebo groups, respectively. Mean HbA1c was 7.8% for the XOMA 052-treated patients and 7.7% for placebo-treated patients.