Clinical TrialJun 5, 2026, 07:01 AM
Climb Bio CLYM116 Phase 1 Data Favorable; Phase 2 in Q3 2026
AI Summary
Climb Bio, Inc. announced favorable initial Phase 1 safety data for its anti-APRIL monoclonal antibody, CLYM116, supporting its continued development for IgA nephropathy (IgAN). The data, presented at the ERA Congress 2026, showed CLYM116 was generally well tolerated with no unexpected safety findings in healthy volunteers. The company's partner, Mabworks, expects to initiate dosing in IgAN patients for a Phase 2 study in Q3 2026, and Climb Bio plans to share further data in late summer.
Key Highlights
- Climb Bio announced favorable initial Phase 1 safety data for CLYM116, its anti-APRIL monoclonal antibody.
- Mabworks, Climb Bio's partner, expects to initiate CLYM116 dosing in IgAN patients for a Phase 2 study in Q3 2026.
- CLYM116 was generally well tolerated in Phase 1 studies in healthy volunteers at doses up to 320 mg.
- Preliminary safety data from 49 healthy volunteers showed no unexpected safety findings or serious adverse events.
- All observed adverse events were mild to moderate (Grade 1-2), transient, and self-resolving.
- A translational PK/PD model suggests the potential for less-frequent dosing of CLYM116.
- Climb Bio maintains global rights to CLYM116 outside of Greater China.
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