Dimerix hits milestone in fight with kidney disease
Dimerix (ASX:DMX), an Australian biotechnology company currently undergoing clinical-stage trials of its flagship drug DMX-200, has announced a significant milestone in reaching 10 patients.
DMX-200 combines irbesartan and propagermanium in the treatment of chronic kidney disease (CKD) and has been shown to improve the outcome of CKD by reducing proteinuria by more than 50% in animal tests.
DXB announced it is on track to report interim data from its DMX-200 Phase II trial in patients with CKD after accumulating 11 patients.
Dimerix’s proprietary screening assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT), was used to identify DMX-200 and formed the basis of an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. The assay enables the identification of pairs of receptors that interact when ligands, small molecule drugs, peptides or antibodies, and then bind to them.
In addition to its own therapeutic programs, DXB also earns revenue by providing this technology to global pharmaceutical firms.
DMX-200 combines two existing drugs, a chemokine receptor CCR2 blocker (propagermanium) used for its anti-inflammatory properties, and an angiotensin II type I receptor blocker (irbesartan) which is registered in the USA for hypertension and treatment of diabetic nephropathy in certain patients.
Dimerix Executive Chairman Dr. James Williams said, “The milestone of dosing 10 patients is an important one, as it should enable interim information to be elucidated under the trial. It confirms we are meeting the recruitment targets and timelines previously communicated to the market.”
Finfeed interviewed Mr. Williams in late March 2016, discussing DXB’s kidney disease research, its recent progress as well as future plans.
Dimerix is conducting its clinical trial in two parts.
Part A trials dose escalation trial in up to 30 patients. All patients are provided with stable irbesartan therapy and orally treated with propagermanium three times per day. The plan is for each patient to commence on 30mg PPG/day with the dose incrementally raised every 28 days up to a maximum of 240mg PPG/day, or until proteinuria is absent or reduced.
Reducing proteinuria reduces the risk of CKD progression and its consequences of progressive loss of renal function leading to renal failure, and the development and progression of cardiovascular disease.
Part B constitutes an expansion study for DXB in which up to 30 more patients are enrolled with the best dose identified from Part A. DXB expects to review the design of Part B in consultation with the United State Food and Drug Administration (FDA) before embarking on Part B. Dimerix aims to provide an interim data analysis based on 10-15 patients in the trial before the end of the third quarter of 2016.