Climb Bio’s Budoprutug Subcutaneous Shows Robust B-Cell Depletion, Fast Track for pMN
Climb Bio’s budoprutug subcutaneous formulation achieved robust B-cell depletion matching intravenous dosing with favorable safety in healthy volunteers, supporting advancement to patient studies. The company holds FDA Fast Track designation for primary membranous nephropathy and anticipates initial ITP data in June plus pMN and SLE readouts in Q4 2026.
1. Subcutaneous Formulation Data
Robust B-cell depletion was observed in healthy volunteers following subcutaneous administration of budoprutug, matching intravenous dosing at identical levels. The formulation was generally safe and well-tolerated, paving the way for patient studies at full depleting doses.
2. Clinical Trial Timelines
Climb Bio is enrolling trials in primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus as planned. Initial ITP data from the 250 mg cohort is expected in June 2026, with pMN and SLE readouts slated for Q4 2026.
3. Regulatory Progress
The FDA has granted Fast Track designation for budoprutug in primary membranous nephropathy, enhancing development support and review. Orphan Drug designation for pMN further underscores the therapy’s potential in rare autoimmune conditions.
4. Development Strategy and Outlook
The company is advancing both intravenous and subcutaneous formulations to broaden clinical adoption across multiple B-cell mediated diseases. Targeting CD19 aims to achieve profound peripheral and tissue-level depletion, offering potential durable disease control.