SanBio Co., Ltd. and Sumitomo Dainippon Pharma Co., Ltd. announced that a Phase 2b study conducted in the U.S. evaluating SB623, a regenerative cell medicine under development for the treatment of patients with chronic motor deficits due to ischemic stroke, did not meet its primary endpoint. The study examined the efficacy and safety of SB623 in 163 patients with motor deficits associated with chronic ischemic stroke. The 163 patients were randomized to one of three treatment groups: 2.5 million SB623 cells, 5 million SB623 cells, and a sham surgery (control) group.

The primary endpoint of the study was the proportion of patients whose Fugl-Meyer Motor Scale (FMMS) improved at least 10 points from baseline at six months after treatment. The SB623 treatment groups did not demonstrate a statistically significant improvement compared to the control group, and did not meet its primary endpoint. Additionally, no safety issues were observed for SB623.

The additional analyses of the study results are being conducted. Based on the additional analyses, SanBio and Sumitomo Dainippon Pharma will consider future development plans of SB623. The results of the study will be presented at future scientific congresses and elsewhere.