Dimerix commences study of DMX-200 in FSGS patients

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Clinical-stage biopharmaceutical company Dimerix (ASX: DXB) has commenced the phase three ACTION3 clinical study in patients with focal segmental glomerulosclerosis (FSGS).

The company said up to 167 sites in up to 18 countries across North America, South America, Europe, United Kingdom, and Asia Pacific regions are expected to participate in this study, with Australia and New Zealand identified as the first countries planned to initiate patient recruitment across five sites.

The study, which is a pivotal, multi-centre, 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, aged 18 to 75 years, will be randomised to receive either DMX-200 (120 mg capsule twice daily) or placebo.

The primary endpoint is the per cent change in protein in the urine (proteinuria) from baseline to Week 35 following treatment with DMX-200 compared with placebo. The primary endpoint for full approval is the slope of eGFR from Baseline to Week 104 following treatment with DMX-200 compared with placebo.

The company said a blinded interim analysis will be performed in approximately 70 patients following part one of the study to confirm both efficacy and study powering (for statistical measures), which based on the estimated patient recruitment rate, is anticipated as early as the December quarter of 2022.

"The decision to continue the study will be made by an independent data monitoring committee based on the results of this interim analysis. If the study is recommended to proceed, the remaining 180 patients will be enrolled into Part 2 of the study," said the company.

“The team at Dimerix is delighted to have commenced the operational activities for the ACTION3 study in FSGS patients. We are well on track to begin patient recruitment for the study once ethics approval has been achieved, with first patient screening expected to be in Q4 2021," said CEO and managing director, Dr Nina Webster.

"We have designed interim analyses into the Phase 3 study design to capture evidence of proteinuria and kidney function improvement during the study, aimed at generating sufficient data to support an accelerated marketing approval.

"With the key regulators’ expectations aligned, including the US FDA and the European EMA, and the encouraging data reported in the prior Phase 2a study, we are excited to deliver on the FSGS program, potentially providing patients with a much-needed treatment option.”