What is CLYM116 from Climb Bio (NASDAQ:CLYM)?

CLYM116 is Climb Bio’s lead “sweeper” anti-APRIL monoclonal antibody, designed as a potential treatment for IgA nephropathy (IgAN), an autoimmune kidney disease.

What phase of clinical testing is CLYM116 in?

CLYM116 is currently in Phase 1 trials, assessing safety and pharmacokinetics in healthy volunteers before moving to patient studies.

How many participants were involved in the Phase 1 trial?

Approximately 80 healthy volunteers participated in a dose-escalation study, receiving doses ranging from 25 mg to 640 mg.

Were there any serious safety issues reported?

No serious adverse events or dose-limiting toxicities were reported. Observed side effects were mild to moderate and transient, supporting a favorable safety profile.

What does the pharmacokinetic data show?

Pharmacokinetic data from both healthy volunteers and non-human primates were used in translational modeling, helping refine dose selection for future clinical trials.

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Climb Bio unveils promising Phase 1 results for IgAN candidate CLYM116

Written by Heidi Cuthbert Published Jun. 5 2026Last Updated Jun. 5 2026

Climb Bio (NASDAQ:CLYM) announced initial Phase 1 safety and pharmacokinetic data for its lead product candidate, CLYM116, at the 2026 European Renal Association (ERA) Congress in Glasgow.

The data, derived from healthy volunteers, provide critical validation for the company’s "sweeper" anti-APRIL monoclonal antibody as it advances toward potential treatment for IgA nephropathy (IgAN).

Clinical findings from the ongoing Phase 1 program—conducted in Australia by Climb Bio and in China by its development partner, Beijing Mabworks Biotech—indicate that CLYM116 was generally well tolerated.

Across a dose-escalation study involving approximately 80 participants receiving doses ranging from 25 mg to 640 mg, researchers reported no serious adverse events and no dose-limiting toxicities.

Observed adverse events were categorized as mild to moderate and transient in nature, supporting the drug’s potential for a favorable safety profile.

The presentations at the ERA Congress also highlighted successful translational modeling, which utilized pharmacokinetic data from non-human primates and healthy human volunteers to refine dose selection.

This modeling is central to the program's development, as it informs the transition to clinical efficacy studies.

Climb Bio and its partner are currently preparing for the next stage of development, with the initiation of Phase 2 dosing for patients diagnosed with IgAN expected in the third quarter of 2026.