Dimerix To Start Recruitment Of Patients In Kidney Trial of DMX-200

Dimerix Ltd (ASX:DXB) shares rose after the Independent Data Monitoring Committee (IDMC) confirmed the dose of DMX-200 to be used in adolescent patients aged 12-17 years participating in the ACTION3 clinical trial.

This allows the recruitment of adolescent patients into the ACTION3 Phase 3 global clinical trial in patients with focal segmental glomerulosclerosis (FSGS).

DMX 200 is the adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker – the standard of care treatment for hypertension and kidney disease.

Adequate safety margin

The adolescent-approved dose is the same as the 120mg adult dose currently being administered in the ACTION3 Phase 3 trial which is given orally and twice daily.

The IDMC noted “the safety margin [of DMX-200] should allow [the ACTION3 Phase 3] clinical study to proceed in this adolescent population using adult doses.”

About 15 specialist paediatric nephrology centres across the UK, USA, Mexico, Brazil and Argentina have been selected to recruit adolescent patients with FSGS.

Area of high unmet need

Dimerix Chief Medical Officer Dr David Fuller said: “The positive recommendation of the IDMC to allow adolescent dosing, further extends the strong safety profile and tolerability of DMX-200 when used in FSGS patients.

“This is especially important as paediatric FSGS remains an area of high unmet need with limited therapeutic options and a high risk of progression to end-stage kidney disease.”

Dimerix is well funded with cash position of A$35.2 million at 31 March 2024.

 

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