Shanghai Shen Lian's UB-221 Meets Primary Endpoint in Phase II Clinical Trial
核心洞察
Shenlian Bio (搜索)'s subsidiary Shizhiyuan reported positive topline Phase II results for UB-221 injection in moderate to severe chronic spontaneous urticaria (搜索).
The trial enrolled 145 patients randomized to three UB-221 doses, omalizumab 300 mg, or placebo, with the primary endpoint met at Week 12.
Complete wheal resolution rates were 54%, 53% and 43% for UB-221 4, 2 and 1 mg/kg versus 11% for placebo and 41% for omalizumab.
Shenlian Bio (搜索) (688098.SH) said its controlled subsidiary Yangzhou Shizhiyuan Biotechnology (搜索) achieved the primary endpoint in a Phase II study of UB-221 injection, a Class 1 biologic it developed independently for chronic spontaneous urticaria (搜索) (CSU). The multicenter, randomized, double-blind, placebo-controlled, parallel-group trial evaluated the drug as add-on therapy and produced positive topline results.
The study enrolled 145 patients with moderate to severe CSU, randomized 2:2:2:1:1 to UB-221 at 4 mg/kg, 2 mg/kg or 1 mg/kg, omalizumab 300 mg, or placebo. On the primary endpoint of HSS7 = 0 (complete wheal resolution) at Week 12, response rates were 54%, 53% and 43% for the 4, 2 and 1 mg/kg groups versus 11% for placebo (p < 0.005, p < 0.005 and p < 0.05) and 41% for omalizumab. The key secondary endpoint of UAS7 = 0 (complete resolution of wheals and pruritus) at Week 12 showed rates of 46%, 39% and 38% across UB-221 doses, with the 4 mg/kg group reaching significance versus placebo (p < 0.05), compared with 29% for omalizumab.
UB-221 is a humanized monoclonal antibody given subcutaneously that targets IgE (搜索), neutralizing free IgE and blocking its interaction with receptors on mast cells and basophils. It does not interfere with IgE binding to CD23 (搜索) on B cells, a feature the company says may reduce IgE synthesis and give the drug a distinct mechanism of action. Efficacy continued to improve after Week 12, with the 4 mg/kg group reaching an HSS7 = 0 rate of 69% at Week 22 and 60% at Week 28, versus 24% for omalizumab at the same time points. UB-221 was generally well tolerated, with similar rates of treatment-related adverse events across groups and no treatment-related serious adverse events or hypersensitivity reactions, including anaphylaxis. The company said the dose-response and sustained efficacy support advancing UB-221 into a Phase III trial in CSU.
Source: moomoo