XOMA 052 Phase 2b Top Line Results: Glucose Control Not Demonstrated, Positive Anti-inflammatory Effect, Cardiovascular Biomarke
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Today : Wednesday 23 March 2011
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XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that its Phase 2b trial of XOMA 052 in Type 2 diabetes patients did not achieve the primary endpoint of reduction in glycosylated hemoglobin, or 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 (p < or = 0.0005) 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 (p<0.05) 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. XOMA is developing XOMA 052 in collaboration with Servier.
"While this trial did not demonstrate glycemic improvement, the potent anti-inflammatory effects and continued positive safety profile reinforce our Phase 3 development program for Behcet's uveitis, which we anticipate starting this year pending completion of regulatory agency discussions. We are also encouraged by the improvements in C-reactive protein and 'good' cholesterol, which support the further evaluation of XOMA 052 in cardiovascular disease and other inflammatory indications," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer.
"Pending completion of the ongoing Phase 2a trial and analyses of both studies, we will be working with XOMA to determine the next steps in the XOMA 052 diabetes program. In parallel, we anticipate initiating the Phase 3 program in Behcet's uveitis this year. We also expect to take XOMA 052 into clinical development in cardiovascular disease in 2012," said Isabelle Tupinon-Mathieu, M.D., Head of Therapeutic Research and Development, Servier.
Phase 2b Trial Top Line Results
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. Mean duration of Type 2 diabetes was approximately six years in both groups.
At six months, all XOMA 052 doses had reductions in CRP, with adjusted mean percent changes from baseline that were highly significant compared to placebo with p-values (adjusted for multiple comparisons) at 0.0005 or less. Consistent with prior XOMA 052 studies, the median reductions in this trial were 33% to 54% in the four dose groups, compared with zero reduction for placebo.
In addition, despite the fact that more than half of the patients were receiving lipid-lowering medication, XOMA 052-treated patients demonstrated statistically significant increases in high-density lipoprotein, or "good" cholesterol, in two of the four XOMA 052 dose groups versus placebo (p<0.05).
The safety and tolerability profile in this population was consistent with previous XOMA 052 clinical trials, and there were no serious drug-related adverse events. The most common adverse events were upper respiratory infections with no differences between XOMA 052 and placebo groups. There were no reported opportunistic infections.
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