Climb Bio and Mabworks announced additional Phase 1 clinical data for CLYM116/MIL116, an anti-APRIL monoclonal antibody in development for IgA nephropathy. The results from healthy volunteer trials demonstrated a ~70% reduction in galactose-deficient IgA1 (Gd-IgA1) and approximately 60% suppression of IgA at 12 weeks following an 800 mg dose. The data also showed greater than 90% free APRIL suppression sustained through the dosing interval, supporting a potential every-12-week regimen with a ~33-day half-life. CLYM116 was generally well tolerated with no serious adverse events. Climb Bio is currently enrolling patients in its NAVIGATE-2 Phase 2 trial and expects to initiate a global Phase 3 trial in 2027, pending regulatory feedback. The company operates as a clinical-stage biotechnology firm developing therapies for immune-mediated diseases.
