>90% free APRIL suppression sustained through 12 weeks, supporting Q12W dosing interval
~70% reduction in Gd-IgA1 at 12 weeks
~33-day half-life
NAVIGATE-2 Phase 2 trial enrolling, with initial data expected in the first half of 2027
Global Phase 3 trial expected to initiate in 2027
WELLESLEY HILLS, Mass. and BEIJING, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (NASDAQ:CLYM, "Climb Bio"))) and Beijing Mabworks Biotech Co., Ltd. ("Mabworks"), today announced additional Phase 1 data in healthy volunteers for CLYM116/MIL116, an anti-APRIL monoclonal antibody (mAb), in development for IgA nephropathy (IgAN). These data were presented at the American Society of Nephrology (ASN) Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado.
CLYM116/MIL116 is being evaluated in complementary Phase 1 trials in Australia and China. Both are randomized, double-blind, placebo-controlled, ascending-dose studies designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) CLYM116/MIL116 in healthy volunteers and enrolled 46 and 42 participants respectively.
Near-complete free APRIL suppression was sustained through 12 weeks following a single SC dose ≥480 mg. Following a single 800 mg dose, ~70% reduction in Gd-IgA1 and ~60% reduction in IgA were observed at 12 weeks. PK was consistent across both studies. Exposure was linear, with no target-mediated drug disposition (TMDD) observed across the effective dose range. Together, these PK and PD data support an every 12-week (Q12W) dosing regimen. CLYM116/MIL116 has been generally well tolerated, with no dose limiting toxicities, treatment-related serious adverse events (SAEs), or hypogammaglobulinemia. The NAVIGATE-2 Phase 2 trial is currently enrolling IgAN patients to confirm the Q12W dosing regimen, and a global Phase 3 trial is expected to initiate in 2027, pending regulatory feedback.