Climb Bio Inc.
06/05/2026 | Press release | Distributed by Public on 06/05/2026 05:13
Material Event (Form 8-K)
| Item 8.01 |
Other Events. |
On June 5, 2026, Climb Bio, Inc. (the "Company") announced translational pharmacometric modeling and initial Phase 1 safety data for CLYM116, its anti-APRIL monoclonal antibody:
| • |
A translational pharmacokinetic/pharmacodynamic model derived from pooled non-human primate ("NHP") data projected healthy human exposure and dose-dependent IgA suppression for CLYM116, suggesting the potential for less-frequent dosing than first generation anti-APRIL approaches. |
| • |
Literature analysis shows strong correlation in IgA reduction between NHP and healthy volunteer studies. |
| • |
Global Phase 1 strategy, incorporating parallel healthy volunteer datasets ex-China and China (n≈80, doses 25 mg to 640 mg), expected to support a robust population pharmacokinetic foundation to inform dose selection. |
| • |
CLYM116 has been generally well tolerated based on preliminary safety data from healthy volunteers receiving single doses up to 320 mg or placebo (n=49), with no unexpected safety findings reported to date. |
| o |
No serious adverse events, dose limiting toxicities, or adverse event related discontinuations observed. |
| o |
All adverse events observed were mild to moderate (Grade 1-2), transient, and self-resolving. |
| o |
Injection site reactions observed in two patients, both Grade 1, and resolved without intervention. |
These clinical data include results from a Phase 1 study being conducted by the Company in Australia, and a parallel ongoing Phase 1 study being conducted by the Company's partner, Beijing Mabworks Biotech ("Mabworks"), in China. With the safety profile observed to date and supportive preclinical data, the Company plans to continue to advance CLYM116 into further clinical development, and Mabworks expects to initiate dosing in IgAN patients in the Phase 2 portion of its ongoing study in the third quarter of 2026.
Climb Bio Inc. published this content on June 05, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on June 05, 2026 at 11:13 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]