Dimerix has regulatory win in kidney disease fight
Dimerix (ASX:DXB) will be able to continue its phase II trial of flagship drug DMX-200 after it got the sign-off from the Therapeutic Goods Administration to do so.
It is currently undergoing phase II trials of the chronic kidney disease-fighting drug on two patients. The trials are almost complete.
DMX-200 combines two existing drugs, one which has anti-inflammatory properties and another one which is used to treat hypertension.
The latter doesn’t need sign-off, but the former does.
The TGA needs to approve the supply of the former, propagermanium, to patients on a case-by-case basis.
With approval in hand, the patients will now need clinician approval and to sign a participant agreement.
Pursuant to those, the patients will embark on a 24 week treatment period as part of the phase II trial.
DXB is currently on the lookout for up to 30 patients to test at four sites in Melbourne, with the aim of demonstrating that DMX-200 can safely reduce the level of proteinuria in the body.
Proteinuria is the presence of abnormal levels of protein in urine, which can be an indicator of chronic kidney disease in a patient.
Reducing proteinuria lowers the chances of CKD progression and its consequences such as the loss of renal function, and the development and progression of cardiovascular disease.
DMX chairman Dr James Williams said the approval would help in recruiting more patients in the trial, and was an endorsement of using the two drugs present in DMX-200 together.
“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,” he said.
“We believe this will support further recruitment into the trial.”