CLYM116 data show 90% APRIL suppression at ASN Kidney Week
WELLESLEY HILLS, Oct. 23: Climb Bio, Inc. and Beijing Mabworks Biotech Co., Ltd. announced Phase 1 data for CLYM116/MIL116, an anti-APRIL monoclonal antibody, showing that free APRIL suppression of 90% or more was sustained for 12 weeks. The companies presented these findings at the American Society of Nephrology Kidney Week 2026, held from October 21 to 25 in Denver, Colorado. The data, derived from two complementary randomized, double-blind, placebo-controlled trials in Australia and China, evaluated the safety, pharmacokinetics, and pharmacodynamics of subcutaneous administration in healthy volunteers. A total of 88 participants enrolled across the two studies, with 46 in the Australian trial and 42 in the Chinese trial.
WELLESLEY HILLS, Oct. 23: Climb Bio, Inc. and Beijing Mabworks Biotech Co., Ltd. announced Phase 1 data for CLYM116/MIL116, an anti-APRIL monoclonal antibody, showing that free APRIL suppression of 90% or more was sustained for 12 weeks. The companies presented these findings at the American Society of Nephrology Kidney Week 2026, held from October 21 to 25 in Denver, Colorado. The data, derived from two complementary randomized, double-blind, placebo-controlled trials in Australia and China, evaluated the safety, pharmacokinetics, and pharmacodynamics of subcutaneous administration in healthy volunteers. A total of 88 participants enrolled across the two studies, with 46 in the Australian trial and 42 in the Chinese trial.
Following a single subcutaneous dose of 800 mg, the data indicated a reduction of approximately 70% in Gd-IgA1 and approximately 60% in IgA levels at the 12-week mark. Pharmacokinetic analysis revealed linear exposure with no target-mediated drug disposition observed across the effective dose range. The estimated half-life was approximately 33 days based on mean absolute dose levels of 800 mg and 320 mg. These pharmacokinetic and pharmacodynamic profiles support a dosing regimen every 12 weeks. Safety data showed the drug was generally well tolerated across all evaluated dose levels, ranging from 25 mg to 1280 mg, with no dose-limiting toxicities, treatment-related serious adverse events, or hypogammaglobulinemia reported. Injection site reactions were infrequent, occurring in five of the 88 participants; all were Grade 1 and resolved without intervention.
Aoife Brennan, President and Chief Executive Officer of Climb Bio, stated that the complementary datasets validate what the company views as a best-in-class anti-APRIL profile for IgA nephropathy. She noted that the engineered "sweeper" mechanism translated into superior in vivo potency and extended half-life. Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks, said the consistency of findings across both studies encourages the company to move with urgency to generate data in patients. Li highlighted strong enrollment momentum in the ongoing NAVIGATE-2 Phase 2 trial, which is currently enrolling IgA nephropathy patients to confirm the every-12-week dosing regimen.
The NAVIGATE-2 trial is expected to release initial data in the first half of 2027. A global Phase 3 trial is anticipated to initiate in 2027, pending regulatory feedback. Climb Bio retains worldwide rights to CLYM116/MIL116 outside of Greater China, while Mabworks retains rights within Greater China. The antibody targets APRIL, a driver of pathogenic B-cell activity, utilizing a pH-dependent bind-and-release mechanism to block signaling and promote lysosomal degradation.