According to the Zhitong Finance App, Yiming Angko-B (01541) announced that the phase II/III trial of IMM0306 to treat IgG4-related diseases (IgG4-RD) successfully completed the first patient administration. IgG4-rd is a chronic, progressive fibrous inflammatory disease that may affect multiple organ systems, including the pancreas, bile ducts, salivary glands, lacrimal glands, and retroperitoneal tissue. In severe cases, the disease can cause organ failure. Existing immunosuppressive treatments are still limited by low response rates and high recurrence rates. Inebilizumab (an anti-CD19 monoclonal antibody) is currently the only approved biotherapy, and there are still significant unmet clinical needs. Studies have shown that abnormal B-cell activation and IgG4-positive plasma cell infiltration are the core pathological mechanisms of IgG4-RD, which is highly consistent with the mechanism of action of IMM0306.

The phase II/III clinical trial (registration number: CTR20262001) aims to evaluate the efficacy of iMM0306 in reducing the risk of disease recurrence in IgG4-RD patients, and use this as its primary endpoint. Secondary endpoints focus on evaluating the safety, tolerability, population pharmacokinetic characteristics, and immunogenicity of the drug. Subjects will receive an intravenous infusion once a week for 4 weeks and repeat the dosing regimen at week 27.

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