Dimerix (ASX:DXB) has received final data from the PARASOL collaboration, reinforcing support for the company’s proteinuria-based endpoints in its Phase 3 ACTION3 study for Focal Segmental Glomerulosclerosis (FSGS).
FSGS is a progressive kidney disorder that leads to scarring of the glomeruli, the filtering units of the kidney, causing severe proteinuria and often leading to end-stage renal disease. Patients typically face kidney failure within five years of diagnosis, and recurrence after transplant occurs in up to 60 per cent of cases, underscoring the urgent need for new, disease-modifying treatments.
FSGS is a rare and severe kidney disease with no approved therapies.
The PARASOL analysis, drawn from major renal registries, was designed to validate the link between proteinuria reduction and the risk of kidney failure, providing key evidence to support US Food and Drug Administration (FDA) discussions on both traditional and accelerated approval pathways.
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The analysis confirmed that proteinuria reduction at 12 months may be predictive of long-term kidney outcomes, offering a potential basis for earlier approval under the FDA’s accelerated program. These findings build on earlier PARASOL results from 2024, which had already established the relevance of proteinuria as a regulatory endpoint for FSGS trials.
“The PARASOL collaboration outcome is in line with our expectations,” said Dr David Fuller, Dimerix Chief Medical Officer. “It demonstrates a clear relationship between proteinuria at both the 12- and 24-month time points and subsequent risk of kidney failure. We look forward to discussing these findings with the FDA in due course.”
The data indicate that both percentage change from baseline and responder analyses, which measure the number of patients achieving a clinically meaningful reduction in proteinuria, are suitable for use as primary endpoints at 104 weeks in the company’s pivotal Phase 3 program.
Dimerix said it plans to engage the FDA in the coming months to align on these endpoints and explore whether a 12-month proteinuria analysis could support an accelerated submission. The company’s US partner, Amicus Therapeutics, will participate in these discussions as part of the joint development plan.
The ACTION3 trial, short for Angiotensin II Type 1 Receptor and Chemokine Receptor 2 Targets for Inflammatory Nephrosis, is a global Phase 3, double-blind, placebo-controlled study evaluating Dimerix’s lead candidate, DMX-200, in patients with FSGS who are receiving standard therapy. The trial includes two interim analyses assessing proteinuria and kidney function (measured by eGFR slope) to generate sufficient evidence for marketing approval.
Dimerix CEO Dr Nina Webster said the collaboration highlights the importance of global research partnerships in tackling rare diseases.
“This is another significant step toward delivering a much-needed therapy for patients living with FSGS,” she said. “We are encouraged by the consistency of the data and the potential regulatory flexibility it may offer.”