Melbourne-based clinical-stage biopharmaceutical company Dimerix (ASX:DSB) has updated on clinical trials of its drug candidate DMX-200 for kidney diseases.
The update is based on the latest results of its phase two clinical trial evaluating the safety and efficacy of DMX-200 in 40 individuals with diabetic kidney disease (DKD).
DMX-200 is aimed at reducing the levels of proteins in the urine. High protein levels can be a sign of kidney damage (albuminuria) that indicates the patient has too much of a specific blood protein, albumin, in their urine.
The clinical trial's primary endpoint was the per cent change in albuminuria from baseline after 12 weeks of treatment with DMX-200 compared to placebo.
The company confirmed the trial did not show a statistically significant difference in reduction of albuminuria. It said a subsequent analysis showed "statistically and clinically significant variation in treatment response for 26 patients with higher levels of albuminuria at study baseline."
"In the trial, 64% of DKD patients with higher starting proteinuria levels demonstrated a clinically significant reduction in their albuminuria when receiving DMX-200 compared to placebo," it said.
"These results are consistent with previous studies of DMX-200 in chronic kidney disease (CKD) and focal segmental glomerulosclerosis (FSGS), where patients with starting high levels of albuminuria experienced clinically significant reductions in their albuminuria."
The results of this latest trial follow the results of previous trials that show DMX-200 can be effective in the treatment of FSGS.
FSGS is caused by scarring in the kidney that can lead to kidney damage and failure. There are no currently approved treatments for FSGS.
DMX-200 has been granted Orphan Drug Designation for FSGS in the US and Europe. The company also supplies DMX-200 to Australian patients on a 'compassionate use' basis under the TGA's Special Access Scheme.
Dimerix is also studying DMX-200 in patients with Acute Respiratory Distress Syndrome (ARDS).