Dimerix Limited (ASX:DXB) Marks Milestone with First Paediatric Patient in ACTION3 Trial
Trial Overview
Dimerix Limited (ASX: DXB) has successfully recruited the first paediatric patient for the ACTION3 Phase 3 clinical trial, a significant step towards obtaining marketing approval for its product DMX-200. This trial specifically focuses on children aged 12-17, who are being recruited from 19 specialist clinical sites across Argentina, Mexico, the United Kingdom, and the United States.
Patient Profile
The chosen dosage for the paediatric cohort will match that of adult participants, administrating DMX-200 at 120 mg twice daily. This decision follows an evaluation of interim safety and pharmacokinetic data, confirming that the treatment is safe for this age group. The ACTION3 trial is primarily aimed at children suffering from Focal Segmental Glomerulosclerosis (FSGS), a critical condition causing kidney failure.
Future Recruitment Plans
Dimerix anticipates the interim data collection to conclude by August 2025, with full recruitment expected by late Q3 2025. The trial includes randomisation where patients will unknowingly receive either DMX-200 or a placebo, followed up over a two-year period. Should the outcomes prove successful, Dimerix aims to expand the approval of DMX-200 into paediatric markets.
Implications for Dimerix
Dr David Fuller, Chief Medical Officer of Dimerix, commented, “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.” He acknowledged the enthusiasm surrounding the opening of additional study sites and plans for full recruitment later this year.
Dimerix remains focused on navigating this critical phase in their clinical journey, aiming to generate substantial evidence for regulatory approval by both the FDA and EMA in the near future.
Motley Fool contributor Aaron Shaw has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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