Dimerix (ASX:DXB) says it has navigated another important step in the development of its lead compound DMX-200 for the treatment of kidney disease.
The company said its medical advisory board unanimously recommended that DMX-200 should progress to a phase three clinical trial in 2021 in kidney disease focal segmental glomerulosclerosis (FSGS).
Studies show half of all children who acquire FSGS are likely to endure kidney failure within five years.
The disease, in which scar tissue develops in the glomeruli – the capillary networks that work as the microscopic filtration units in the kidney – and degrades their effectiveness, has no approved treatment.
Yet there are estimated to be about 210,000 people with FSGS in the world, with cases of the disease growing at a global compound annual growth rate of 8 per cent – and more than 5,400 new cases diagnosed in the US alone, each year.
The company said DMX-200 works in chronic kidney diseases by blocking the 'signalling' process by which inflammatory cells move to the kidney, and preventing the subsequent onset of fibrosis (scarring), by which chronic kidney disease progresses.
"DMX-200 has demonstrated this effectiveness through its ability to reduce the levels of protein in the urine, which is a sign of kidney damage," said the company. "It has been shown that any reduction in proteinuria could yield years of kidney function and delay the onset of kidney failure and the need for dialysis or transplant."
Dimerix said it will now submit an investigational new drug (IND) application to the US FDA for the phase three FSGS clinical study in the first half of 2021 and initiate the study on clearance from the FDA.
The FDA and Medicines Agency (EMA) have granted DMX-200 an orphan drug designation.