(RTTNews) - Dimerix Limited (DXB.AX) has completed adult patient enrolment in its pivotal ACTION3 Phase 3 trial of DMX-200 for focal segmental glomerulosclerosis, successfully dosing its 286th patient and marking a major step toward potential approval.
Focal segmental glomerulosclerosis (FSGS) is a progressive condition characterized by scarring in the kidney's filtering units, leading to proteinuria and eventual kidney failure. Current treatment options are limited, and many patients progress to dialysis or transplantation.
The ACTION3 trial is a multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of DMX-200 when added to standard angiotensin II receptor blocker (ARB) therapy. Patients are randomized to receive either DMX-200 (120 mg capsule, twice daily) or placebo for a two-year treatment period. The primary endpoints include reduction in proteinuria and preservation of kidney function, measured by eGFR slope.
Of the 286th adult patients dosed, 69 have already completed the full two-year treatment period, and 65 of those voluntarily entered the open-label extension study, representing a 94% uptake. The trial has passed seven scheduled independent Data Monitoring Committee reviews without protocol changes or safety concerns. Recruitment of paediatric patients remains ongoing as an independent cohort, and if successful, may allow Dimerix to expand its application for DMX-200 to adolescents in key territories.
Following the successful PARASOL collaboration data analysis, a global initiative validating proteinuria as a surrogate endpoint, Dimerix and its U.S. partner Amicus Therapeutics plan to seek FDA feedback on proposed clinical trial endpoints before conducting a blinded analysis of ACTION3 data.
Dimerix maintains a strong cash position to fund ongoing operations, including the ongoing ACTION3 Phase 3 clinical trial, as well as to assess new R&D opportunities.
DXB.AX closed at AU$0.60, up 0.83%. over the past year the stock has traded between AU$0.30 and AU$0.78.
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