Core Insights - Climb Bio, Inc. announced promising preclinical data for CLYM116, an anti-APRIL monoclonal antibody, showing deeper IgA reduction and a longer half-life compared to the first-generation antibody sibeprenlimab [1][3][4] Company Developments - CLYM116 is set to enter a Phase 1 trial in healthy volunteers, expected to begin in Q4 2025, with initial biomarker and dosing interval data anticipated by mid-2026 [1][5][7] - The company is hosting a virtual investor event on September 29, 2025, featuring nephrologist Craig E. Gordon, who has extensive experience in treating IgA nephropathy [2][3] Product Profile - CLYM116 is characterized as a "sweeper" anti-APRIL monoclonal antibody, demonstrating a subcutaneous formulation with high bioavailability (~85%) and a favorable tolerability profile [7][10] - The antibody exhibits a 2-3 times longer half-life compared to sibeprenlimab and achieves over 70% maximal reduction in IgA after a single administration at equivalent doses [7][10] Market Opportunity - IgA nephropathy (IgAN) represents a significant market opportunity, estimated at $10-20 billion in the U.S. alone, with a high unmet need for effective treatments [6][12] - The updated KDIGO 2025 guidelines emphasize the need for more active management of IgAN, potentially expanding the market opportunity for CLYM116 [3][12] Clinical Context - IgAN is the most common primary glomerular disease worldwide, affecting approximately 170,000 patients in the U.S. and typically requiring lifelong management [12] - The KDIGO guidelines recommend stricter proteinuria control and highlight the importance of reducing pathogenic IgA, positioning anti-APRIL therapy as a core treatment approach for IgAN [12]
Climb Bio Announces CLYM116 Preclinical Data Highlighting Potential for Best-In-Class Therapeutic for IgAN