Biotechnology company Dimerix Bioscience Ltd’s (ASX:DXB) has dosed 10 patients in an open label Phase II trial of its novel combination therapy DMX 200 for adult patients with chronic kidney disease (CKD).
DMX-200 combines two existing drugs, irbesartan and propagermanium.
Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients.
While propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti-inflammatory properties.
DMX-200 has been shown to improve the outcome of chronic kidney disease by reducing proteinuria by more than 50 per cent in animal models.
The primary end points of the trial are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants.
The secondary end points are obtained from statistical analysis of biomarker data at each time point including change from baseline.
In addition, it is the proportion of responders defined as those participants achieving normalisation of proteinuria (proteinuria within normal limits) or those participants achieving a 50 per cent reduction in proteinuria.
The trial has two parts. 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.
In total 11 patients have been dosed and the first two patients recruited have completed the dose escalation stage.
The investigators will escalate the patients’ dose to 60, 90, 150 and 240mg per day over each four week period.
Dimerix is on track to provide an interim data analysis based on 10 to 15 patients in the trial before the end of Q3 2016.
Proteinuria is common in CKD patients and is a strong independent risk factor for disease progression.
The Australian Research Council, an Australian Government entity, had recently awarded a $499,000 Linkage Grant to a consortium that includes Dimerix.
The grant will be paid over three years and will expedite the development of Dimerix’s proprietary screening assay.
The company is well funded with a cash balance of $2.4 million as on 31 March 2016.
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