Dimerix Limited (ASX: DXB) a biopharmaceutical company with a Phase 3 clinical study in inflammatory diseases, today confirmed that the first 72 patients have been randomised in its DMX-200 ACTION3 phase 3 trial in patients with FSGS kidney disease. Following recruitment, patients were required to complete the background medication stabilisation period and subsequent re-screening, before being randomised to receive either drug or placebo. With randomisation of the first cohort of patients complete, the final data collection is scheduled on 26 February 2024, with the Part 1 interim outcome expected to be announced on, or around, 15th March 2024.1 The trial continues to recruit patients for Part 2 of the trial.2
The Phase 3 study, 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), multicentre, randomised, double-blind, placebo-controlled study 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 will be randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support accelerated marketing approval. A successful outcome in the first interim analysis outcome, expected on or around 15 March 20241, would see the Company announce a clinically significant and statistical meaningful improvement in proteinuria in patients on DMX-200 vs placebo and that the trial is continuing to Part 2.
Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785).
Orphan Drug Designation
Dimerix has received Orphan Drug Designation for DMX-200 in both the US7 and Europe8, and the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK9, for the treatment of FSGS. These designations provide regulatory and financial benefits to help bring new drugs to market faster, including reduced fees during the product development phase, protocol assistance from the regulatory authorities, and 7-year (US) and 10-year (Europe) market exclusivity following product approval.