Action3 Phase 3 Kidney Trial to Begin Recruiting Adolescent Patients

Dimerix Limited (ASX: DXB) has confirmed the dose of DMX-200 for adolescent patients aged 12-17 participating in the ACTION3 clinical trial, allowing recruitment to commence. The approved adolescent dose matches the adult dose currently used in the trial. The decision was based on safety and pharmacokinetic data from the adult cohort, aligning with US FDA advice and EMA's approved Paediatric Investigation Plan. This step holds significance in potentially treating children globally with FSGS, a leading cause of kidney failure in pediatric patients. Around 15 specialist pediatric nephrology centers across several countries will participate in adolescent patient recruitment.

An independent IDMC review, in line with good clinical practice, involves assessing study data for participant safety, conduct, and progress. The IDMC is tasked with making recommendations on continuing, modifying, or terminating the trial.

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