Approval Probability
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Also known as TNT119
Budoprutug · 4 trials · 8 indications
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Number of participants with clinically significant laboratory abnomalities.
Number of incidences of dose-limiting toxicities (DLTs)
Mean change from baseline in diastolic blood pressure (mmHg).
Mean change from baseline in systolic blood pressure (mmHg).
Mean change from baseline in heart rate (bpm).
Mean change from baseline in respiratory rate
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| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Level A | EXPERIMENTAL | - |
| Cohort 2: Dose Level B | EXPERIMENTAL | - |
| Cohort 3: Dose Level C | EXPERIMENTAL | - |
| Dose Expansion Cohort | EXPERIMENTAL | Single IV dose at Day 1 and Day 15 |
| Cohort 4: Dose Level D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| budoprutug | DRUG | Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183 |
Inclusion Criteria: * Confirmed diagnosis of PMN with positive anti-PLA2R antibodies * CD19+ B cell count ≥40 cells/μL * UPCR ≥2.0 g/g * eGFR ≥35 mL/min/1.73 m² * Stable RAAS inhibitor therapy * Blood pressure \<150/90 mmHg at baseline * Adequate hematologic, hepatic, and renal function * Willing t...
Budoprutug is an investigational small molecule developed by Climb Bio, Inc. (ticker CLYM) that targets CD19. It is being studied in immune thrombocytopenia, primary membranous nephropathy, and systemic lupus erythematosus. Budoprutug remains in clinical development and is not approved for any indication.
Budoprutug targets CD19, a surface protein expressed on B cells. By binding CD19, the drug is designed to act on B cell driven immune processes. This CD19-directed mechanism underlies its study in autoimmune and immune-mediated conditions such as immune thrombocytopenia, primary membranous nephropathy, and systemic lupus erythematosus.
Budoprutug is being developed by Climb Bio, Inc., which trades under the ticker CLYM. Climb Bio is the sponsor of the clinical program evaluating budoprutug across immune thrombocytopenia, primary membranous nephropathy, and systemic lupus erythematosus.
Budoprutug is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. Studies include Phase 1b and Phase 1b/2a trials in systemic lupus erythematosus and immune thrombocytopenia, plus a Phase 2 trial in primary membranous nephropathy.
Budoprutug is being evaluated in four recruiting trials: NCT07564596, a Phase 1b/2a study in systemic lupus erythematosus in China; NCT07096843, a Phase 2 study in primary membranous nephropathy across the United States, Argentina, Brazil, China, Georgia, Taiwan, and Ukraine; NCT07043946, a Phase 1b/2a study in immune thrombocytopenia; and NCT07011043, a Phase 1b study in systemic lupus erythematosus.
Budoprutug is being studied as an investigational treatment for immune thrombocytopenia, or ITP, a condition in which the immune system destroys platelets. The Phase 1b/2a trial NCT07043946 is evaluating budoprutug in adults with ITP and is currently recruiting participants in Bulgaria, Greece, Serbia, Spain, and Ukraine.