• First paediatric patient (12-17 years old) recruited for ACTION3 Phase 3 clinical trial
• Total of 19 specialist paediatric clinical sites across 4 countries to recruit paediatric patients
• DMX-200 paediatric development plan aims to collect data for potential marketing approval in children over 1 year old

Dimerix Limited has recruited the first paediatric patient (12-17 years old) for the ACTION3 Phase 3 clinical trial of its product candidate DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a leading cause of kidney failure in children. A total of 19 specialist paediatric clinical sites across Argentina, Mexico, the United Kingdom, and the United States will recruit patients into the ACTION3 trial to support the inclusion of the paediatric population. The DMX-200 paediatric development plan aims to collect sufficient data for potential marketing approval in children over 1 year old, in accordance with the FDA and EMA expectations. FSGS is one of the leading causes of kidney failure in children, with 20% of all presentations of Nephrotic Syndrome in paediatric patients caused by FSGS. The recruitment of the first paediatric patient is a significant milestone, and the study is entering an exciting phase as the remaining study sites are opened and full recruitment is targeted for late Q3/2025, with a blinded interim analysis anticipated in August 2025.

The recruitment of the first paediatric patient for ACTION3 is highly significant, being the first step towards providing a potential new treatment for children with FSGS. The study is entering a very exciting phase as we open the last remaining study sites and work towards full recruitment later this year, as well as the blinded interim analysis anticipated in August 2025.