CLYM116 trial data announced by Climb Bio and Mabworks on October 23, 2026, showed sustained suppression of the drug’s APRIL target and reductions in disease-related biomarkers in healthy volunteers. The findings support testing an every-12-week dosing schedule for the investigational IgA nephropathy treatment, but do not establish effectiveness in patients.
Key Takeaways
- A single dose of at least 480 mg sustained at least 90% free APRIL suppression through 12 weeks.
- The studies reported no dose-limiting toxicities or treatment-related serious adverse events.
- Initial Phase 2 patient data are expected in the first half of 2027; a Phase 3 start remains subject to regulatory feedback.
Table of Contents
- CLYM116 trial data show durable biomarker reductions
- Early safety findings support continued testing
- Patient results are the next development milestone
- Conclusion
CLYM116 trial data show durable biomarker reductions
Climb Bio and Mabworks presented the findings at the American Society of Nephrology Kidney Week in Denver. Their Phase 1 results announcement describes two complementary studies in Australia and China evaluating the safety, tolerability and behavior of CLYM116/MIL116 after subcutaneous administration.
At 12 weeks after a single 800 mg dose, participants showed approximately 70% lower levels of galactose-deficient IgA1, or Gd-IgA1, and approximately 60% lower IgA levels. The companies selected 800 mg as the loading dose for the ongoing NAVIGATE-2 Phase 2 trial.
Gd-IgA1 is involved in the immune complexes that accumulate in the kidneys of people with IgA nephropathy, causing inflammation and scarring. Lowering that biomarker is relevant to the drug’s intended mechanism, but a change in healthy volunteers is not evidence that the treatment preserves kidney function in patients.
| Item | Details |
|---|---|
| Australia study | 46 healthy volunteers |
| China study | 42 healthy volunteers |
| Study design | Randomized, double-blind, placebo-controlled, ascending-dose trials |
| Dose range evaluated | 25 mg to 1,280 mg |
| Estimated half-life | Approximately 33 days |
Early safety findings support continued testing
The companies said CLYM116/MIL116 was generally well tolerated, with no dose-limiting toxicities, treatment-related serious adverse events or hypogammaglobulinemia reported. That safety statement does not mean that no serious adverse events of any kind occurred.
Injection-site reactions occurred in five of the 88 participants across both studies. All were Grade 1 and resolved without intervention.
Drug exposure was consistent across the studies and increased linearly over the effective dose range. Together with sustained APRIL suppression, these findings underpin the companies’ proposed 12-week dosing interval, which still needs confirmation in patients.
Patient results are the next development milestone
NAVIGATE-2 is enrolling people with IgA nephropathy to evaluate the proposed dosing regimen. The companies expect initial results in the first half of 2027 and anticipate starting a global Phase 3 trial during 2027, pending regulatory feedback.
Climb Bio holds worldwide rights to CLYM116/MIL116 outside Greater China, while Mabworks retains rights within Greater China. The program remains investigational: the announced results support further development rather than a conclusion that the drug is ready for commercial use.
Conclusion
The next scheduled milestone for CLYM116 is initial NAVIGATE-2 data in the first half of 2027. Those patient findings will be important for assessing whether the healthy-volunteer results support the intended 12-week regimen.
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