WELLESLEY HILLS, Mass., June 5, 2026
Climb Bio, Inc. announced the presentation of initial Phase 1 safety data and translational pharmacometric modeling results for CLYM116, its investigational anti-APRIL monoclonal antibody, at the European Renal Association (ERA) Congress 2026. The early clinical findings demonstrated a favorable safety profile in healthy volunteers and support the continued development of CLYM116 as a potential treatment for IgA nephropathy (IgAN). The company believes the data strengthen the therapeutic rationale for advancing the candidate into further clinical studies and support upcoming Phase 2 development activities planned by its partner, Beijing Mabworks Biotech.
Early Clinical Data Support Continued Development
The preliminary Phase 1 results are based on ongoing studies being conducted by Climb Bio in Australia and by Mabworks in China. Across the studies, CLYM116 was generally well tolerated in healthy volunteers receiving single doses up to 320 mg. Investigators reported no serious adverse events, dose-limiting toxicities, or treatment discontinuations related to adverse events. All reported adverse events were mild to moderate, transient, and resolved without intervention. Only two Grade 1 injection-site reactions were observed, further supporting the candidate’s favorable early safety profile. These findings provide a foundation for advancing the program into patient-focused clinical studies.
Modeling Results Highlight Potential Differentiation
Climb Bio also presented translational pharmacokinetic and pharmacodynamic modeling data designed to predict human exposure and immunological responses. The analyses suggest that CLYM116 may achieve substantial reductions in IgA levels while potentially allowing less frequent dosing compared with first-generation anti-APRIL therapies. The modeling incorporated pooled non-human primate data and was supported by literature analyses demonstrating a strong correlation between IgA reduction observed in animal studies and healthy volunteer data. According to the company, the emerging evidence indicates that CLYM116 could offer a differentiated treatment approach for patients with IgA nephropathy, a chronic kidney disease characterized by progressive kidney damage and limited treatment options.
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Phase 2 Patient Dosing Planned for 2026
Building on the encouraging safety and translational findings, Mabworks expects to begin dosing patients with IgA nephropathy in the Phase 2 portion of its ongoing clinical study during the third quarter of 2026. Climb Bio retains global rights to CLYM116 outside Greater China and plans to provide additional updates later this year. The company intends to share initial pharmacokinetic and pharmacodynamic results, updated safety findings, and further development plans during its upcoming R&D Spotlight Series event scheduled for late summer. As development progresses, Climb Bio aims to establish CLYM116 as a potentially disease-modifying therapy capable of addressing key drivers of immune-mediated kidney disease while offering a differentiated dosing profile for patients.
Source: Climb Bio, press release
