Sun Biomedical (ASX:SBN) has enrolled the first patient in the Phase II clinical study of its DMX-200 treatment for chronic kidney disease.
The primary goal of the study will be to quickly demonstrate the safety of DMX-200 in patients with chronic kidney disease. Secondary endpoints include reduction of levels of protein in the urine in patients with the disease.
DMX-200 combines a drug called irbesartan, an off-patent compound used to treat hypertension and nephropathy in Type II diabetic patients and propagermanium, which is used for the treatment for Hepatitis B in Japan and available as a dietary supplement in the U.S.
The trial is a single arm, open label two-part trial in adult patients with chronic kidney disease.
Part A is a dose escalation trial recruiting up to 30 patients.
All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day.
Interim analysis will be carried out to confirm the safety of the therapy and observe any biomarker changes on up to 15 patients. Interim data is expected to be available by mid-2016.
Part B is an expansion study, in which up to 30 patients are recruited on the best dose identified from Part A.
The trial has commenced at three sites in Melbourne, Australia, and may be expanded into other jurisdictions to meet recruitment targets and regulatory goals.
Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation specifically in the kidneys. Proteinuria is the most common manifestation of the disease.
As the disease progresses it can lead to end-stage renal disease (ESRD) where the kidneys fail. The only treatment for ESRD is a kidney transplant or regular dialysis treatments.
More than 26 million people suffer from the disease in the United States.
The company had $2.9 million in cash, deposits and proceeds of shares yet to be issued as at 30th June 2015.
