Biopharmaceutical company Dimerix (ASX:DXB) announced an operational breakthrough in its flagship ACTION3 Phase 3 clinical trial for DMX-200.
The company confirmed that the study has "over-recruited," with the final patient in this cohort now having received their initial dose.
The milestone marks the completion of enrolment for this specific phase of the trial, which is evaluating the efficacy and safety of DMX-200 in patients suffering from focal segmental glomerulosclerosis, a rare and debilitating kidney disease.
By exceeding its recruitment targets, Dimerix has strengthened the statistical robustness of the trial data.
The ACTION3 study is a multi-centre, randomised, double-blind, placebo-controlled trial designed to support global regulatory submissions.
DMX-200 works by targeting the chemokine receptors associated with inflammation and fibrosis in the kidneys.
Given that there are currently limited treatment options for FSGS, the dosing of the final patient brings the company closer to potentially providing a new therapeutic pathway for those with unmet medical needs.
Based in Fitzroy, Victoria, Dimerix continues to focus on its mission of developing innovative therapies for renal and inflammatory diseases.
With dosing now well underway for the full patient group, the company will shift its focus toward data collection and analysis.
Future interim results will be critical in determining the next steps for commercialisation and regulatory approval.
At the time of reporting, Dimerix's share price was $0.38.