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Dimerix Limited (ASX:DXB), a Melbourne-based biopharmaceutical company, has started recruitment for its first paediatric patient for the Phase 3 ACTION3 clinical trial in a major next step for the research.
The trial will investigate the efficacy of DMX-200 in children aged 12 to 17 with focal segmental glomerulosclerosis, a leading cause of kidney failure.
The DMX-200 dosage for participating children will match that given to adults, based on interim safety and pharmacokinetic data evaluations. The goal is to collect sufficient data for potential marketing approval per FDA and EMA guidelines.
“The recruitment of the first paediatric patient for ACTION3 is highly significant,” Dr David Fuller, Chief Medical Officer at Dimerix, declared, “being the first step towards providing a potential new treatment for children with FSGS.”
The recruitment took place at a specialist site in Manchester, marking a significant milestone in the trial’s paediatric study plan. All up, 19 specialist paediatric clinical sites across Argentina, Mexico, the U.K., and the U.S. have been designated for this purpose.
If successful, the study could enable broader marketing approval, including for paediatric use, in critical markets such as the U.S. and Europe.
Interim data from the January trial is now anticipated in August; complete recruitment is slated for the late third quarter.
DXB shares have been up 2.9% at 53.5 cents at 1:30 PM Sydney time.
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