Australian biotech company Dimerix Limited will soon report interim data from its Phase 2 clinical study of DMX-200 in patients with chronic kidney disease (CKD), after 10 patients have been dosed in the trial.
Identified using the company’s proprietary screening assay — Receptor-Heteromer Investigation Technology (Receptor-HIT) — DMX-200 is a combination of the drugs Irbesartan, an off-patent angiotensin 2 type 1 receptor blocker compound, and propagermanium, a chemokine receptor (CCR2) blocker.
“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,” Dimerix Executive Chairman Dr. James Williams said in a recent press release.
Eleven patients have been dosed in the clinical trial and the first two patients enrolled have finished the dose escalation stage. Patients in the study are already being treated with irbesartan and, as part of the study protocol, initiated a daily dose of 30mg of propagermanium. As part of the trial, the researchers are reviewing patients at four-week intervals and escalating patients’ daily dose to 60, 90, 150 and 240 mg at each four-week period.
Patients will be supplied with propagermanium after their participation in the study, subject to the Australian TGA’s Special Access Scheme approval.
Part A of the Phase 2 open label study aims to enroll up to 30 patients at four clinical sites across Melbourne, Australia, to assess the safety of the drug agent and its effectiveness in reducing proteinuria (the presence of abnormal quantities of protein in the urine, usually indicating kidney damage) in CKD patients. Reducing proteinuria can reduce the risk of CKD progression and the progressive loss of renal function that leads to renal failure.
Dimerix expects to report interim data of the 10 to 15 patients in the study before the end of the year.