Xoma has reported positive results from single dose and multiple dose subcutaneous arms of the randomized, placebo-controlled US phase 1 clinical trial of Xoma 052, in type 2 diabetes patients.
Xoma 052 targets interleukin-1 beta (IL-1 beta) protein. The results demonstrate that Xoma 052 is well tolerated in patients. Further, a multiple dose regimen of Xoma 052 showed reductions in glycosylated hemoglobin, HbA1c, and high sensitivity C-reactive protein, hsCRP, compared to a single dose regimen.
Patrick Scannon, executive vice president and CMO of Xoma, said: In the 0.03 mg/kg multiple dose cohort, we observed median reductions of over 50% in CRP and up to 0.6% in HbA1c at day 56, as well as rapid, meaningful and prolonged reductions in fasting blood glucose.
Taken together, these data demonstrate, as expected, the potential for added benefit with multi-dose treatment using XOMA 052. In addition, the 0.03 mg/kg multiple dose median reduction of over 50% in CRP and up to 0.6% in HbA1c at day 56 compares favorably to reductions of 29% and 0.3%, respectively, for a single 0.1 mg/kg dose at the same time point. More patients responded to the multiple dose regimen as well. The bioavailability and pharmacokinetic results enable us to initiate our Phase 2 program using XOMA 052 in monthly or less frequent subcutaneous dose regimens, he added.