Dimerix Limited (ASX: DXB) Achieves Key Milestone in DMX-200 Phase 3 Trial
Recruitment Milestone
Dimerix Limited (ASX: DXB) has announced the successful recruitment and randomisation of 144 patients into its DMX-200 ACTION3 Phase 3 global clinical trial focused on Focal Segmental Glomerulosclerosis (FSGS) kidney disease. This recruitment represents 50% of the total planned enrolment of 286 patients, with completion expected by the third quarter of 2025.
Future Analysis Plans
The company anticipates a blinded interim analysis after 35 weeks of dosing, scheduled for August 2025. The outcome of this analysis will determine the potential for accelerated or conditional approval submissions to regulatory authorities such as the FDA in the United States.
Safety and Data Monitoring
Dimerix has conducted five Independent Data Monitoring Committee reviews of the Phase 3 trial, confirming no safety concerns to date. 14 patients have already completed the full two-year ACTION3 trial and are continuing into the Open Label Extension study.
Executive Comments
Dr Nina Webster, CEO & Managing Director of Dimerix Limited, expressed enthusiasm regarding the recruitment milestone. She stated, “The randomisation of the first 144 patients into our DMX-200 ACTION3 Phase 3 FSGS kidney clinical trial is a major milestone for Dimerix.” Dr Webster highlighted the potential for accelerated approval, which could enable the commercial launch prior to the trial’s full completion.
Orphan Drug Designation
Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe, along with the Innovative Licensing and Access Pathway designation in the UK. These designations may assist in expediting the drug’s development process and subsequent market access.
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