Dimerix Limited Announces That FDA Confirms Inclusion of Paediatrics in Action3 Study of DMX-200 for FSGS
if approved. FSGS is a rare disease that attacks the kidney's filtering units causing irreversible scarring. This leads to permanent kidney damage and eventual end-stage kidney failure, requiring dialysis or transplantation. FSGS affects both adults and children as young as two years old, 9 and for those who are fortunate enough to receive a kidney transplant, 60% of patients have reoccurring FSGS after first kidney transplant.10 Furthermore, FSGS is one of the leading causes of kidney failure in children, with 20% of child nephrotic syndrome cases caused by FSGS.1 At this time, there are no drugs specifically approved for FSGS anywhere in the world, leading to limited treatment options and poor prognosis. About ACTION3 Phase 3 clinical study: The Phase 3 trial, which is titled "Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis" - or ACTION3 for short, is a pivotal (Phase 3), multi- centre, randomised, double-blind, placebo-controlled trial of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients, aged 18 to 80 years (broadening to 12 to 80 years), will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.