MELBOURNE, Australia--(BUSINESS WIRE)--Melbourne-based, clinical-stage biopharmaceutical company Dimerix has reported excellent results from the clinical trial of its drug candidate DMX-200, which is aimed at a rare kidney disease called focal segmental glomerulosclerosis, or FSGS.
FSGS is caused by scarring in the kidney, which can cause kidney damage and failure. 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 2 years old.
There are no treatments approved on the market today, and Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe for FSGS. This is a special status granted to a drug to treat a rare disease or condition and which provides regulatory and financial benefits to help bring DMX-200 to market in the US and Europe faster. In Australia, Dimerix already supplies DMX-200 to patients through compassionate use, as part of the Therapeutic Goods Administration (TGA) Special Access Scheme.
Dimerix has multiple assets in commercially attractive and growing markets that all have a high unmet need, with little or no current marketed competition, and with a potential fast pathway to market. FSGS is exactly the kind of global unmet medical need for which Dimerix applies its ability to develop innovative new therapies.
In June, Dimerix completed the dosing of FSGS patients in its phase 2a clinical trial of DMX-200. All of the patients were already taking irbesartan, which is a drug approved for treating high blood pressure and some kidney conditions. The main purpose of the trial – known in biotech as the “primary endpoint” – was to evaluate the safety of DMX-200 in patients. The secondary purpose – the “secondary endpoint” – was to look for preliminary signs of the drug’s efficacy.
For both of these endpoints, the results hit the mark.
On the primary endpoint, the preliminary safety findings show that DMX-200 was generally safe and well-tolerated: whether treated with DMX-200 or the placebo, there was no variation in the incidence or severity of adverse events between treatment. There were no serious adverse events related to the drug.
On the secondary endpoint, the preliminary results showed efficacy. This 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.
86% of patients showed a benefit on DMX-200 versus placebo, with an average of 29% change from patients’ baseline proteinuria compared to placebo in 24-hour proteinuria following treatment with DMX-200.
Furthermore, 29% of the patients achieved a proteinuria reduction of more than 40% during treatment with DMX-200 compared to placebo.
These are strong and encouraging results, given that there are no current treatments approved anywhere in the world and could equate to a further 3-5 years on the life of the kidney.
"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,” says 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,” Webster adds.
Further trial data support for DMX-200 are just around the corner. “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,” says Webster.
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For further information: www.dimerix.com