Perth-based Sun Biomedical (ASX:SBN) has announced the first patient has been enrolled in a Phase 2 study of DMX-200, a new treatment that combines two different drugs to treat chronic kidney disease.
DMX-200 combines irbesartan, an off-patent compound used to treat hypertension and nephropathy in Type 2 diabetic patients, and propagermanium, which is used for the treatment for Hepatitis B in Japan and is 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 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.
According to Executive Chairman, Dr James Williams, “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,” said Dr Williams.