Clinical TrialJun 5, 2026, 07:21 AM
Climb Bio Reports Positive CLYM116 Phase 1 Safety Data; Advances to Phase 2
AI Summary
Climb Bio, Inc. announced positive translational pharmacometric modeling and initial Phase 1 safety data for CLYM116, its anti-APRIL monoclonal antibody. A model derived from non-human primate data projected dose-dependent IgA suppression, suggesting potential for less-frequent dosing. Preliminary safety data from 49 healthy volunteers showed CLYM116 was generally well tolerated with no serious adverse events. The company plans to advance CLYM116 into further clinical development, and its partner Mabworks expects to initiate Phase 2 dosing in IgAN patients in Q3 2026.
Key Highlights
- Translational PK/PD model from NHP data projected dose-dependent IgA suppression for CLYM116.
- Global Phase 1 strategy incorporates ~80 healthy volunteers (ex-China and China) for dose selection.
- CLYM116 was generally well tolerated in 49 healthy volunteers receiving single doses up to 320 mg.
- No serious adverse events, dose limiting toxicities, or adverse event related discontinuations observed.
- All observed adverse events were mild to moderate (Grade 1-2), transient, and self-resolving.
- Mabworks expects to initiate dosing in IgAN patients in Phase 2 in Q3 2026.
Price Impact
More from CLYM