Climb Bio Adds 800 mg Data: ~70% Gd-IgA1 Cut at 12 Weeks, Phase 3 Set for 2027
CLYM has more than doubled off its 52-week low of $1.635 on light trading volume (0.4× avg).
Summary
Expanded Phase 1 data presented by Climb Bio and Mabworks show a single 480 mg or higher dose of CLYM116 held 90%+ free APRIL suppression through 12 weeks, while the 800 mg NAVIGATE-2 loading dose cut Gd-IgA1 ~70% at 12 weeks. NAVIGATE-2 patient data is expected in the first half of 2027, with a global Phase 3 planned for 2027.
Key Events · Product Development and Regulatory · CLYM
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Expanded Phase 1 Data at ASN Kidney Week
Additional healthy-volunteer data from the Australian and Chinese Phase 1 trials (46 and 42 participants) were presented at ASN Kidney Week 2026, held October 21-25 in Denver.
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Q12W Dosing Supported by 480 mg Threshold
A single subcutaneous dose of 480 mg or higher produced 90% or more free APRIL suppression through the full 12-week interval; the 800 mg NAVIGATE-2 loading dose cut Gd-IgA1 ~70% and IgA ~60% at 12 weeks.
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~33-Day Half-Life, 3.5x Sibeprenlimab
Estimated half-life of approximately 33 days based on the 800 mg and 320 mg MAD cohorts, with linear exposure and no target-mediated drug disposition at doses of 160 mg or higher.
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Clean Safety Through 1280 mg
No dose-limiting toxicities, treatment-related serious adverse events or hypogammaglobulinemia across 25 mg to 1280 mg; injection site reactions in 5 of 88 participants, all Grade 1 and resolved without intervention.
Analysis · CLYM · Life Sciences
What a partner or investor needs to believe the every-12-week dosing claim is exactly what the expanded Phase 1 dataset delivers: a single 480 mg or higher dose held free APRIL suppression at 90%+ for the full 12 weeks, and the 800 mg loading dose chosen for NAVIGATE-2 produced roughly 70% Gd-IgA1 and 60% IgA reductions at 12 weeks. The ~33-day half-life, stated as 3.5x sibeprenlimab's, is the commercial argument for a less-frequent dosing regimen in a crowded IgAN field. Safety held up across 25 mg to 1280 mg with no DLTs, treatment-related SAEs or hypogammaglobulinemia. Concrete next checkpoints: NAVIGATE-2 patient data in the first half of 2027 and a global Phase 3 start in 2027 pending regulatory feedback. Patient data, not healthy-volunteer data, is what decides whether the profile holds.
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At the time of this filing, CLYM was trading at $10.19 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $585.3M. The 52-week trading range was $1.64 to $18.33. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.