- Dimerix (DXB) receives approval in Europe for a clinical trial of its drug DMX-200 in treating kidney disease
- The approval is a milestone for the company as it marks the first time DMX-200 has been approved for use in kidney patients by a regulator outside of Australia and NZ
- Dimerix has selected 73 of the planned 75 global sites across 12 countries to conduct the first part of the phase three study, and 15 of those 75 sites are in Europe
- Recruitment of patients aged 18 to 80 years is expected to commence imminently, starting with Australia, following site initiation including staff training
- Shares have been trading 8.5 per cent higher at 25.5 cents at 2:37pm AEDT
Dimerix (DXB) has received approval in Europe for a clinicial trial of its drug DMX-200 in treating kidney disease.
The approval from the Danish Medicines Agency for the ACTION3 Phase Three Focal Segmental Glomerulosclerosis (FSGS) kidney disease study in Denmark marks the first time DMX-200 has been approved for use in kidney patients by a regulator outside of
Australia and New Zealand.
Focal Segmental Glomerulosclerosis is a rare form of kidney disease that attacks the kidney’s filtering units, the glomeruli, causing irreversible scarring.
According to Dimerix, the average time between diagnosis and complete kidney failure is five years, as there are currently no drugs specifically approved for FSGS treatment options and prognoses are often poor.
The multi-centred, randomised, double-blind and placebo-controlled study has been designed to assess the efficacy and safety of DMX-200 in patients who are receiving a stable dose of an angiotensin II receptor blocker.
It includes two interim analysis points to capture evidence of both proteinuria and kidney function during the study, which the company said is aimed at generating sufficient evidence to support accelerated marketing approval.
Dimerix has selected 73 of the planned 75 global sites across 12 countries to conduct the first part the phase three study, and 15 of those 75 sites are in Europe.
Recruitment of patients aged 18 to 80 years is expected to commence imminently, starting with Australia, following site initiation including staff training.
Shares were trading 8.5 per cent higher at 25.5 cents at 2:37 pm AEDT.