Climb Bio and Mabworks Announce CLYM116/MIL116 Data Demonstrating Deep, Durable APRIL Suppression and ~70% Gd-IgA1 Reduction at ASN Kidney Week 2026
Key Highlights
- ➤≥90% free APRIL suppression sustained through 12 weeks at single SC doses ≥480 mg
- ➤~70% Gd-IgA1 reduction and ~60% IgA reduction at 12 weeks after 800 mg
- ➤NAVIGATE-2 Phase 2 enrolling IgAN patients, with initial data expected in first half of 2027
- ➤Global Phase 3 trial expected to initiate in 2027, pending regulatory feedback
- ➤~33-day half-life supports Q12W dosing; CLYM116 generally well tolerated without treatment-related SAEs
Expert Statements
Aoife Brennan, President and Chief Executive Officer of Climb Bio
“What excites us most about these two datasets is that they offer complementary validation of what we view as a best-in-class anti-APRIL profile for IgA nephropathy”
Aoife Brennan, President and Chief Executive Officer of Climb Bio
“CLYM116 was engineered as a sweeper antibody, and we’ve now seen this mechanism translate into superior in vivo potency, extended half-life, and predictable, linear exposure across two, parallel clinical studies.”
Aoife Brennan, President and Chief Executive Officer of Climb Bio
“This differentiated pharmacokinetic profile drives deep and durable APRIL suppression, leading to substantial reductions in IgA and Gd-IgA1, a key pathogenic driver of IgAN.”
Aoife Brennan, President and Chief Executive Officer of Climb Bio
“Our ability to rapidly generate this body of evidence reflects the strength of our partnership with Mabworks and allows us to accelerate this potentially transformative program into later-stage development.”
Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks
“We are encouraged by the consistency of the findings across both studies, and we continue to move with urgency to generate data in patients”
Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks
“IgA nephropathy affects patients worldwide, carrying a particularly high burden in patients of Asian descent.”
Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks
“Clinicians and patients have responded with real enthusiasm to the prospect of a highly effective anti-APRIL therapy with an extended dosing interval, and that enthusiasm has translated into strong enrollment momentum in the NAVIGATE-2 trial.”
Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks
“Patient data from this ongoing study will allow us to confirm our target Q12W dosing interval and move a single dosing regimen into Phase 3.”
Feng Li, Chairman of the Board, Chief Executive Officer and General Manager of Mabworks
“Together with Climb Bio, we are planning a global registrational study designed to bring MIL116 to patients across geographies as efficiently as possible.”
>90% free APRIL suppression sustained through 12 weeks, supporting Q12W dosing interval
NAVIGATE-2 Phase 2 trial enrolling, with initial data expected in the first half of 2027
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