Dimerix Reports Positive Data Supporting Action3 Study of DMX-200 to Treat Kidney Disease

Dimerix (ASX: DXB) has received final data analysis from the international PARASOL collaboration that reinforces support for proteinuria-based endpoints in its pivotal Phase 3 Action3 study on DMX-200 for the treatment of kidney disease.

The multi-centre, randomised, double-blind, placebo-controlled study is testing the drug’s efficacy and safety in patients with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB).

Once the ARB dose is stable, patients receive either a 120 milligram dose of DMX-200 twice daily, or a placebo.

Kidney Failure Risk Analysis

The PARASOL analysis explored the relationship between proteinuria (or progressive loss of kidney function) and eGFR (estimated glomerular filtration rate) endpoints at 12 and 24 months, along with the subsequent risk of kidney failure.

The results are generally consistent with a previous analysis from 2024 that supported the use of proteinuria as an endpoint for FSGS clinical trials, and Dimerix will use the new data in its US Food and Drug Administration (FDA) application for accelerated approval.

FSGS is a rare and serious kidney disorder characterised by progressive scarring (sclerosis) in parts of the glomeruli, which are the kidney’s filtering units, which leads to proteinuria and end-stage renal disease.

Research is increasingly suggesting that FSGS has inflammatory component, with estimates putting the number of adults and children in the US impacted by the condition at more than 40,000.

Collaborative Effort

Dimerix chief medical officer Dr David Fuller said the positive outcomes fell in line with the company’s expectations.

“The findings are a testament to the collaborative nature of the PARASOL group and we look forward to discussing them with the FDA in due course.”

The FDA confirmed in April that suitable proteinuria primary endpoints could include either the proportion of patients achieving a defined proteinuria reduction compared to the placebo arm, or the percentage change in proteinuria from baseline, after two years of treatment.

Dr Fuller said the company would work with US partner Amicus Therapeutics on a blinded analysis of ACTION3 data to align on 104-week endpoints, and continues to work with its commercial partners across key territories to determine the potential for alternative approval pathways outside of the US.