Sun Biomedical begins DMX-200 Phase II trial for treatment of chronic kidney disease

Sun Biomedical Limited (ASX: SBN) today announced the first patient had been enrolled in a Phase II study of DMX-200, an innovative new treatment that combines two different drugs to treat chronic kidney 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 USA.

The Company has previously published preclinical data showing that combining the drugs blocks an inflammatory response which prevents the kidneys from functioning properly and releasing protein into the urine, called proteinuria.

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.

Sun Biomedical Limited Executive Chairman Dr James Williams said:

We believe DMX-200 has a number of potential advantages over current therapeutic approaches. To expedite our path to market we intend pursuing registration initially for an orphan indication. Analysis of the interim data of up to the first 15 patients in the study will be used to inform and support regulatory paths required to achieve this outcome.

“The phase II study initiated today underscores our commitment to rapidly developing effective new therapies for the unmet needs of patients with chronic kidney disease,” Dr Williams said.