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Climb Bio Announces FDA Fast Track Designation for Budoprutug for the Treatment of Primary Membranous Nephropathy
Global Phase 2 open-label clinical trial in pMN (PrisMN) enrolling, with initial data anticipated H2 2026 WELLESLEY HILLS, Mass., April 07, 2026 (GLOBE
About this update from Climb Bio, Inc.
[{"type":"text","content":"Global Phase 2 open-label clinical trial in pMN (PrisMN) enrolling, with initial data anticipated H2 2026\nWELLESLEY HILLS, Mass., April 07, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to budoprutug, the company’s investigational anti-CD19 monoclonal antibody, for the treatment of primary membranous nephropathy (pMN)—a rare kidney disease for which there are currently no FDA-approved treatments. “Fast Track Designation recognizes both the urgent need for new therapies in pMN and the compelling early clinical activity generated to date with budoprutug,” said Edgar Charles, M.D., Chief Medical Officer of Climb Bio. “This designation provides the opportunity to support and accelerate our budoprutug development efforts and facilitate closer interaction with the FDA as we work to advance budoprutug into later-stage clinical studies for this serious immune-mediated kidney disease.” As previously reported, administration of budoprutug in a completed Phase 1b study in pMN demonstrated complete peripheral B-cell depletion in 100% (5/5) of patients, serologic remission in all (3/3) evaluable patients, and complete or partial clinical remission in all (5/5) participants by week 48. The safety profile was favorable with no clinically significant treatment-related serious adverse events observed. Long-term follow-up data demonstrated durable reductions in proteinuria, supporting further investigation of budoprutug as a potential disease modifying therapy for pMN. Budoprutug is currently being studied in a Phase 2 global open-label, dose-range finding study (PrisMN), which is designed to evaluate pharmacodynamics, including B cells, anti-Phospholipase A2 Receptor (PLA2R) antibody levels, and total immunoglobulin, and preliminary efficacy, including complete and partial remission, in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAAS) inhibition, and to identify a dose for Phase 3 clinical development. Climb Bio anticipates sharing initial data from this study in the second half of 2026. About Primary Membranous Nephropathy (pMN)Primary membranous nephropathy is an autoantibody...