Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obexelimab · 4 trials · 4 indications
Proportion of participants with hemoglobin (Hgb) ≥ 10 g/dL and ≥ 2 g/dL increase from Baseline with no use of blood transfusion or glucocorticoid (GC) rescue therapy.
Proportion of participants who achieve a durable Hgb response (defined as Hgb ≥ 10 g/dL and ≥ 2 g/dL increase from Baseline on at least 3 of 4 consecutive available visits), at the earliest on or after Week 12, with no use of blood transfusion or GC rescue therapy prior to attaining durable response through Week 24.
Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.
Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
| Arm | Type | Description |
|---|---|---|
| Safety and Dose Confirmation Run-in Period (SRP): Obexelimab | EXPERIMENTAL | Obexelimab will be administered as an SC injection for 24 weeks. |
| Randomized Control Period (RCP): Obexelimab | EXPERIMENTAL | Obexelimab will be administered as an SC injection for 24 weeks. |
| Randomized Control Period (RCP): Placebo | PLACEBO_COMPARATOR | Placebo will be administered as an SC injection for 24 weeks |
| ZB012 | EXPERIMENTAL | Obexelimab administered as an SC injection. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as an SC injection. |
| Obexelimab | EXPERIMENTAL | Obexelimab will be administered as a subcutaneous injection for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Obexelimab | DRUG | Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity. |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA. 3. Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin t...
Obexelimab is an investigational monoclonal antibody being developed by Zenas BioPharma, Inc. (ticker ZBIO) for autoimmune and rare diseases. It is in Phase 3 clinical development across several indications, including IgG4-related disease, relapsing multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia.
Obexelimab targets CD19 and FCGR2B. It is an inhibitor designed to engage both targets, and it is being studied in autoimmune conditions where B cells and antibody-producing cells are thought to contribute to disease activity.
Obexelimab is developed by Zenas BioPharma, Inc., which trades under the ticker ZBIO. The company is running the clinical program for the drug across multiple autoimmune and rare disease indications.
Obexelimab is in Phase 3 clinical development. The Phase 3 program includes studies in IgG4-related disease and warm autoimmune hemolytic anemia, while relapsing multiple sclerosis and systemic lupus erythematosus are being evaluated in Phase 2 trials. It is investigational and has not been approved by the FDA.
Obexelimab is being studied in four trials: NCT05662241 in IgG4-related disease (Phase 3), NCT05786573 in warm autoimmune hemolytic anemia (Phase 3, SApHiAre), NCT06564311 in relapsing multiple sclerosis (Phase 2, MoonStone), and NCT06559163 in systemic lupus erythematosus (Phase 2). All are active and not recruiting.
Obexelimab is being evaluated as a treatment for IgG4-related disease in the Phase 3 trial NCT05662241, which enrolled 194 patients across the United States, Europe, Asia, and other regions. The study is randomized, double-blind, and placebo-controlled, and it is currently active but not recruiting participants.