Xoma has reported unsuccessful results from its Phase 2b trial of Xoma 052 in type 2 diabetes patients.
The trial did not achieve the primary endpoint of reduction in glycosylated haemoglobin, or HbA1c, after six monthly treatments with Xoma 052 compared with a placebo.
Xoma 052, however, resulted in highly significant decreases in C-reactive protein (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 demonstrated in two of four Xoma 052 dose groups versus a placebo.
Xoma 052 was well-tolerated without any serious drug-related adverse events, and its safety profile was consistent with previous trials.
The randomised, placebo-controlled dose-ranging Phase 2b trial enrolled 421 patients with type 2 diabetes at multiple sites in the US.
The patients were randomised to receive one of four Xoma 052 doses or placebo monthly over six months via subcutaneous administration.
Xoma chairman and chief executive officer Steven B Engle said that while the trial did not demonstrate glycemic improvement, the potent anti-inflammatory effects and continued positive safety profile reinforce the Phase 3 development programme for Behcet’s uveitis.
“We anticipate starting the Phase 3 development programme this year pending completion of regulatory agency discussions,” Engle added.
Xoma 052, which is being jointly developed by Xoma and Servier, is a monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases and other diseases including cancer.