Dimerix has announced a collaboration with the UK’s National Registry of Rare Kidney Diseases (RaDaR) to boost recruitment for its ACTION3 Phase 3 trial, which is evaluating DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS). This partnership aims to leverage RaDaR's extensive database of over 34,500 patients to identify and engage individuals who meet the trial's inclusion criteria.
Collaboration Details
RaDaR, led by Professor Danny Gale at University College London, is the largest kidney registry in the world. It collates information from 109 hospitals across the UK on patients diagnosed with rare kidney diseases, including FSGS. Under the collaboration, RaDaR will contact UK patients with FSGS who meet the ACTION3 inclusion criteria and provide them with details on how to participate in the trial.
ACTION3 Trial Design
The ACTION3 trial (Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis) is a multi-center, randomized, double-blind, placebo-controlled study. It assesses the efficacy and safety of DMX-200 in FSGS patients already receiving a stable dose of an angiotensin II receptor blocker (ARB). Patients are randomized to receive either DMX-200 (120mg capsule twice daily) or a placebo.
The trial aims to recruit 286 patients across 19 countries and follow them for two years. An interim analysis in March showed that DMX-200 outperformed the placebo in reducing proteinuria in a larger participant group of 72 randomized patients, suggesting a potential for statistically significant and clinically meaningful reduction in proteinuria at the study’s conclusion. The Independent Data Monitoring Committee (IDMC) has affirmed no safety concerns related to DMX-200.
A further blinded interim analysis is planned after the first 144 patients reach 35 weeks of treatment, with results expected around mid-2025. The study is designed to capture evidence of proteinuria and kidney function (eGFR slope) to support marketing approval.
FSGS: An Unmet Medical Need
FSGS is a rare disease attacking the kidney’s filtering units (glomeruli), leading to irreversible scarring, permanent kidney damage, and eventual end-stage kidney failure requiring dialysis or transplantation. The prognosis is poor, with an average of only five years from diagnosis to complete kidney failure. Approximately 60% of kidney transplant recipients experience a recurrence of FSGS in the transplanted kidney.
Currently, there are no drugs specifically approved for FSGS worldwide, creating a significant unmet medical need. The FSGS market is substantial, affecting more than 80,000 people in the US and around 220,000 worldwide.
Thai FDA Approval
Dimerix has also received approval for its Investigational New Drug Application from the Thai Food and Drug Administration, a prerequisite for trial initiation in Thailand. Recruitment is expected to begin at clinical sites in Thailand in the coming weeks.
Expert Commentary
Dr. David Fuller, Chief Medical Officer at Dimerix, expressed confidence that the collaboration with RaDaR would enhance recruitment rates in the UK. Professor Daniel Gale, Chair of the UK Rare Diseases Committee, UK Kidney Association, noted that RaDaR participants are keen to explore research trials that could address the unmet medical need in FSGS.
