- Dimerix (DXB) is granted Australian ethics and regulatory approval for its Phase 3 clinical trial in FSGS kidney patients
- The clinical trial will see the company evaluate the efficacy and safety of DMX-200 against a placebo in patients with Focal Segmental Glomerulosclerosis (FSGS) kidney disease
- More than half of the 75 global sites have been selected to conduct part one of the study, with five sites located in Australia
- Dimerix says it anticipates starting recruitment and screening during the quarter ending December 2021
- Dimerix was up 3.70 per cent, trading at 28 cents at 11:07 am AEDT
Dimerix (DXB) has been granted Australian ethics and regulatory approval for its Phase 3 clinical trial in FSGS kidney patients.
The clinical trial, named ACTION3, will see the company evaluate the efficacy and safety of DMX-200 against a placebo in patients with Focal Segmental Glomerulosclerosis (FSGS) kidney disease.
FSGS is a rare disease that attacks the kidney’s filtering units where blood is cleaned, resulting in irreversible scarring. This leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation.
The single Phase 3 study has been designed to capture evidence of both proteinuria and kidney function, with the hope of generating enough evidence to support accelerated marketing approval.
More than half of the roughly 75 global sites have been selected to conduct part one of the study, with five sites located in Australia.
Clinical sites will be initiated country by country, based on several factors, including speed of regulatory and ethics submissions and reviews.
“Following the encouraging Phase 2a study data reported in 2020, we are excited to deliver on the DMX-200 program for FSGS patients who currently have few treatment options,” CEO and Managing Director of Dimerix Nina Webster said.
“Our preparations to initiate sites globally are well underway and receiving this first ethics and regulatory approval is a significant milestone for the company,” Dr Webster said.
Dimerix said it anticipates starting recruitment and screening during the quarter ending December 2021.
Dimerix was up 3.70 per cent, trading at 28 cents at 11:07 am AEDT.