ACTION3 Clinical Trial Milestone Recruitment Update

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Stock Dimerix Ltd (DXB.ASX)
Release Time 13 Jun 2025, 8:58 a.m.
Price Sensitive Yes
 Dimerix Achieves Milestone in FSGS Trial Recruitment
Key Points
  • 200 adult patients randomized and dosed, representing ~70% of total trial cohort
  • Recruitment on track to complete dosing of all 286 adult patients in H2 2025
  • 43 patients have completed the full 2-year study and entered the Open Label Extension
Full Summary

Dimerix Limited, a biopharmaceutical company developing innovative therapies for inflammatory diseases, has provided an update on the progress of its ACTION3 Phase 3 clinical trial in patients with focal segmental glomerulosclerosis (FSGS). A total of 200 adult patients, out of a total recruitment target of approximately 286 adult patients, have now been recruited and dosed in the trial, representing a significant milestone. This accounts for around 70% of the total adult patient cohort. Based on anticipated recruitment rates at each site, the company expects to complete the full recruitment of patients into the trial in the second half of calendar year 2025. The ACTION3 Phase 3 clinical trial has activated over 190 clinical sites in 22 countries around the world, and the trial has successfully passed six reviews of the trial safety data by the Independent Data Monitoring Committee (IDMC). In addition, a total of 43 patients have now completed the full 2-year ACTION3 study treatment period and have subsequently entered into the company's Open Label Extension study.

Outlook

Dimerix continues to focus on recruitment into the ACTION3 Phase 3 clinical trial of both adults and paediatric patients, as well as licensing opportunities with potential partners in territories not already licensed.