Dimerix to continue supplying propagermanium to kidney disease patients

The TGA’s special access scheme has granted clinical-stage biotech company Dimerix (ASX:DXB) the right to continue supplying propagermanium to participants in its DMX-200 clinical trial, upon clinician approval and participant agreement.

DMX-200 is a combination of two existing drugs: a chemokine receptor CCR2 blocker (propagermanium) used for its anti-inflammatory properties and not on the Australian Register of Therapeutic Goods (ARTG); and an angiotensin II type I receptor blocker (irbesartan) registered for treatment of hypertension. The DMX-200 clinical trial is currently demonstrating the drug combination in patients with chronic kidney disease (CKD).

Preclinical testing of DMX-200 in models relevant for kidney disease showed a significant reduction in proteinuria — ie, the presence of abnormal quantities of protein in the urine — which is common in CKD patients. Reducing proteinuria reduces the risk of CKD progression and its consequences of progressive loss of renal function and the development and progression of cardiovascular disease.

The Phase II trial is recruiting up to 30 patients at a total of four sites across Melbourne with the aim of demonstrating safety and reduction of proteinuria at 24 weeks of treatment in CKD patients. The TGA approval is on a case-by-case basis and relates to the first two participants in the study, who will shortly complete the treatment period.

“Approval under the special access scheme is significant,” said Dimerix Executive Chairman Dr James Williams. “All trial participants are already on irbesartan; thus, continuing access to propagermanium indicates that the investigators involved do not have any safety concerns and consider there is potential benefit for patients to continue on the treatment. We believe this will support further recruitment into the trial.”

Dimerix (ASX:DXB) shares closed 14.29% higher at $0.008 on Tuesday, the day of the announcement. They were trading 12.5% lower at $0.007 as of around 4 pm on Wednesday.