Dimerix reports positive results from DMX-200 trial

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Melbourne-based biopharmaceutical company Dimerix (ASX:DXB) has reported positive results from the clinical trial of its drug candidate DMX-200.

The drug is aimed at a rare kidney disease called focal segmental glomerulosclerosis, or FSGS, which is caused by scarring in the kidney.

The disease attacks the tiny filtering units inside a person’s kidney where blood is cleaned, known as glomeruli. FSGS leads to permanent kidney damage and kidney failure in both adults and children as young as two years old. 

There are no currently approved treatments.

Dimerix has received Orphan Drug Designation for DMX-200 for FSGS in both the US and Europe. In Australia, Dimerix already supplies DMX-200 to patients through compassionate use, as part of the TGA's Special Access Scheme. 

The company said it completed the dosing of FSGS patients in its phase 2a clinical trial of DMX-200. All of the patients were already taking irbesartan - a drug approved for treating high blood pressure and some kidney conditions.

The trial's primary endpoint was to evaluate the safety of DMX-200. The secondary endpoint was efficacy. 

The company said the preliminary safety findings show DMX-200 was generally safe and well-tolerated. The preliminary results also showed efficacy.

Efficacy was measured by comparing the level of proteinuria (increased levels of protein in the urine, which can be a sign of kidney damage) of trial patients being treated with DMX-200 against the levels in patients being treated with the placebo. 

The company said 86 per cent of patients showed a benefit on DMX-200 versus placebo. There was an average of 29 per cent change from patients’ baseline proteinuria compared to placebo in 24-hour proteinuria following treatment with DMX-200. 

In addition, 29 per cent of the patients achieved a proteinuria reduction of more than 40 per cent during treatment with DMX-200 compared to placebo. 

"We are very pleased with the top-line results from the study, which suggest DMX-200 could be a significant advancement in the treatment of FSGS,” said Dr Nina Webster, CEO and managing director of Dimerix. 

“FSGS patients today face poor outcomes with limited medical options, and we continue to progress our proposed development pathway, which could deliver a much-needed pharmacologic treatment to the FSGS community."

 “In the very near future we will report on the larger Phase 2 study of DMX-200 in diabetic kidney disease, that we hope will also further support the growing evidence of our drug’s treatment effect in kidney diseases,” added Dr Webster.