| XOMA confirmed it has completed patient enrollment in the company's Phase 2 proof-of-concept, or POC, study designed to evaluate the potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with active inflammatory, erosive osteoarthritis of the hand, or EOA, and elevated C-reactive protein, or CRP, levels. XOMA's study enrolled approximately 90 patients who were randomized 2:1 to receive 60mg of gevokizumab dosed subcutaneously once monthly or placebo. The study was designed and powered to detect a significant improvement from baseline versus placebo in the mean Australian/Canadian Hand Osteoarthritis Index pain score in the target hand at Day 84. The study also is capturing multiple outcome measures, including pain, stiffness, physical function, X-ray, radiographic and MRI changes, as well as changes in CRP and concomitant acetaminophen use, at three and six months. The company anticipates having preliminary top-line data for the AUSCAN score in October. XOMA also provided an update on the EOA study in patients with non-elevated CRP. This study was opened for enrollment in May, and investigators have enrolled approximately 40 patients of the targeted 90 who had qualified for the original EOA study with the exception that they did not have elevated CRP levels. This supplemental study will help inform the design of the potential Phase 3 studies of gevokizumab in EOA. |
