Climb Bio Advances Multi-Drug Pipeline with Phase 2 Trial Initiation and 2026 Data Readouts Expected
核心洞察
Climb Bio (搜索) has initiated Phase 2 trials for budoprutug in primary membranous nephropathy (搜索) and multiple Phase 1 studies across immune-mediated diseases, with initial data expected in the second half of 2026.
The company's anti-CD19 (搜索) monoclonal antibody budoprutug is being evaluated in three lead indications including primary membranous nephropathy (搜索), immune thrombocytopenia (搜索), and systemic lupus erythematosus (搜索).
CLYM116, an anti-APRIL (搜索) monoclonal antibody with a novel pH-dependent "sweeper" mechanism, has entered Phase 1 trials for IgA nephropathy (搜索) treatment.
Climb Bio (搜索) has positioned itself for a data-rich 2026 with the initiation of multiple clinical trials across its pipeline of immune-mediated disease therapeutics, including the advancement of budoprutug into Phase 2 development and the clinical entry of CLYM116.
The clinical-stage biotechnology company announced significant progress across its dual-asset portfolio, with first patient dosing achieved in the PrisMN Phase 2 trial evaluating budoprutug in primary membranous nephropathy (搜索) (pMN) in November 2025. Initial data from this pivotal study is expected in the second half of 2026.
"We are now primed for a fulsome evaluation of budoprutug, our anti-CD19 (搜索) monoclonal antibody, with the initiation of four clinical trials and the clearance of our China IND," said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio (搜索). "Looking ahead, 2026 is poised to be a transformative and data-rich year for Climb, with initial readouts expected from all our ongoing trials."
Budoprutug Advances Across Multiple Indications
Budoprutug, an anti-CD19 (搜索) monoclonal antibody designed with enhanced effector function and low picomolar affinity, targets and depletes CD19-expressing B cells, including plasma blasts that are key sources of pathogenic autoantibodies. The therapeutic has demonstrated B-cell depletion and shows potential to treat a broad range of B-cell mediated diseases.
The PrisMN Phase 2 trial is designed to evaluate pharmacodynamics including B cells, anti-PLA2R (搜索), and total immunoglobulin, as well as preliminary efficacy including complete and partial remission in pMN patients with persistent proteinuria despite optimized RAAS inhibition. The study aims to identify a dose to carry forward into Phase 3 clinical development. In November 2025, the company published budoprutug pMN Phase 1b long-term outcome data at the American Society of Nephrology Kidney Week that demonstrated long-term control of proteinuria.
Beyond pMN, dosing is ongoing in budoprutug's Phase 1b/2a trial in relapsed/refractory immune thrombocytopenia (搜索) (ITP), designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts. The company presented trial design details at the 2025 American Society of Hematology conference in December.
Climb Bio (搜索) is also conducting a global Phase 1b trial of a single dose of budoprutug in moderate to severe systemic lupus erythematosus (搜索) (SLE) to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. In December 2025, the company received clearance of its investigational new drug application in China to initiate a separate, parallel China Phase 1b trial in SLE, which will complement the ongoing study and seek to enroll SLE patients who have lupus nephritis (搜索).
A subcutaneous formulation of budoprutug is also under development, with first cohorts dosed in a Phase 1 trial in healthy volunteers designed to evaluate bioavailability, pharmacokinetics, and pharmacodynamics, including B cell depletion. This formulation aims to enable broader patient access and potential home-based dosing. Budoprutug has been granted orphan drug designation by the FDA for the treatment of pMN.
CLYM116 Enters Clinical Development
CLYM116, a clinical-stage monoclonal antibody targeting APRIL (搜索) (A Proliferation-Inducing Ligand), represents Climb Bio (搜索)'s second major asset. APRIL is a key driver of pathogenic B-cell activity in autoimmune diseases, and CLYM116 employs a novel pH-dependent bind-and-release "sweeper" mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL, and recycle the antibody to extend its half-life.
This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL (搜索) with a favorable safety profile and less frequent dosing. CLYM116 is being advanced for the treatment of IgA nephropathy (搜索) (IgAN) and may have broader utility across other B-cell mediated diseases where APRIL plays a critical role.
In December 2025, Climb Bio (搜索) achieved first patient dosing and completed dosing of the first cohort in the ongoing Phase 1 clinical trial in healthy volunteers to evaluate safety, pharmacokinetics, and pharmacodynamics. The company obtained exclusive rights to develop and commercialize CLYM116 outside of Greater China through a technology transfer and exclusive license agreement with Beijing Mabworks Biotech (搜索) Co., Ltd. entered into in January 2025.
2026 Clinical Milestones and Financial Position
The company has outlined an ambitious timeline for 2026 data readouts across its pipeline. For budoprutug, initial data from the subcutaneous formulation Phase 1 study in healthy volunteers is expected in the first half of 2026, with first patient dosing in the China SLE Phase 1b trial also anticipated in the first half of the year. Initial data from the PrisMN Phase 2 trial, ITP Phase 1b/2a trial, and SLE Phase 1b trial, including preliminary efficacy data, are all expected in the second half of 2026.
For CLYM116, initial data from the Phase 1 healthy volunteer study is anticipated in mid-2026.
"With CLYM116 for IgAN, budoprutug in pMN, ITP, and SLE, and the potential to evaluate lupus nephritis (搜索) in a separate, parallel China SLE trial, our pipeline has the potential to address the high unmet need which exists across renal and other B-cell mediated diseases," continued Dr. Brennan.
Climb Bio (搜索) maintains a strong financial position with cash, cash equivalents, and marketable securities expected to fund operations into 2028. The company achieved 20 regulatory clearances to conduct clinical trials and activated 45 trial sites globally in 2025, demonstrating robust clinical execution capabilities.
The company has also strengthened its leadership team with key appointments including Edgar D. Charles, M.D., MSc as Chief Medical Officer, Perrin Wilson, Ph.D., as Chief Business Officer, and Susan Altschuller, Ph.D., MBA as Chief Financial Officer, while adding industry veterans Kim Cobleigh Drapkin, CPA and Bo Cumbo to its Board of Directors.