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Dimerix (ASX:DXB) has recently announced a significant collaboration with the UK’s National Registry of Rare Kidney Diseases (RaDaR) to enhance its ACTION3 Phase 3 clinical trial for DMX-200, aimed at treating focal segmental glomerulosclerosis (FSGS). This partnership will leverage RaDaR’s extensive database to identify and recruit suitable patients for the trial.
RaDaR, led by Professor Danny Gale from University College London, is the largest kidney disease registry globally. It holds records of over 34,500 patients across 109 UK hospitals, supported by the UK Kidney Association and funded by several prominent research organizations.
Under the collaboration, RaDaR will identify UK patients with FSGS who meet the trial’s inclusion criteria. These patients will be provided with details on how to participate in the ACTION3 trial, which will assess the efficacy of DMX-200. Recruitment for this trial is expected to commence in Thailand shortly, following the approval of DXB’s Investigational New Drug Application by the Thai Food and Drug Administration.
The Challenge of FSGS
Focal segmental glomerulosclerosis is a rare disease that causes irreversible damage to the kidney’s filtering units, leading to end-stage kidney failure. The average progression from diagnosis to kidney failure is approximately five years. This condition affects both adults and children and currently lacks specific approved treatments, creating a significant need for new therapeutic options. The global FSGS market includes more than 80,000 affected individuals in the US and around 220,000 worldwide.
ACTION3 Phase 3 Trial Overview
The ACTION3 trial, officially named Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis, is a pivotal study evaluating DMX-200’s efficacy and safety. The trial is a multi-center, randomized, double-blind, placebo-controlled study involving 286 patients across 16 of the planned 19 countries.
Patients in the trial are randomized to receive either DMX-200 (120mg twice daily) or a placebo while on a stable dose of an angiotensin II receptor blocker (ARB). The study aims to determine if DMX-200 can significantly reduce proteinuria, with interim results showing promising efficacy compared to the placebo.
An interim analysis in March indicated DMX-200’s potential for reducing proteinuria in a larger group of 72 patients, surpassing earlier Phase 2 results. The trial’s Independent Data Monitoring Committee has also confirmed that there are no safety concerns related to DMX-200.
Enhanced Recruitment Prospects
DXB’s collaboration with RaDaR is expected to boost recruitment rates in the UK. Dr. David Fuller, DXB’s Chief Medical Officer, expressed optimism about the partnership, highlighting RaDaR’s ability to connect with FSGS patients across the UK. Professor Daniel Gale from the UK Kidney Association also welcomed the collaboration, noting the importance of addressing the unmet medical needs of patients with rare kidney diseases.
The next interim analysis of the ACTION3 trial is anticipated around mid-2025, with the study designed to provide sufficient evidence to support marketing approval for DMX-200.
