US FDA IND approval for Dimerix late-stage study

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Dimerix (ASX:DXB) has received approval from the US FDA to proceed with the Phase 3 study of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS).

FSGS is a kidney condition that can affect kidney function and lead to ‘chronic kidney disease’.

The company said the Investigational New Drug (IND) application for the ACTION3 clinical study is now active, paving the way for patient recruitment in the US.

The ACTION3 Phase 3 study will recruit across 75 sites in 12 different countries globally, with 19 of those clinical sites having been selected in the US. Ethics and regulatory submissions have been made in all 12 countries, with all activated sites proactively screening for suitable patients.

Dimerix CEO and managing director Dr Nina Webster said, “FDA approval of our IND for the Phase 3 FSGS study is an important milestone, as it includes regulatory review of all manufacturing, nonclinical and clinical data that we have generated for the DMX-200 program to date, and we are delighted to be in a position to recruit patents as we strive towards finding new and much-needed treatments for patients with FSGS.”