A drug developed by biopharmaceutical company Dimerix and identified using technology created at The University of Western Australia has successfully passed efficacy interim analysis in a trial to treat a rare kidney disease.
The phase three clinical trial of DMX-200 is assessing treatment of patients with focal segmental glomerulosclerosis (FSGS), a chronic condition which can lead to kidney failure.
The efficacy interim analysis assesses data early to determine whether or not the drug is having the desired effect.
Analysis of the first 72 randomised patients with FSGS indicated that DMX-200 had performed better than the placebo in reducing proteinuria, a high level of protein in urine that is a marker of kidney disease progression.
Dimerix Chief Medical Officer Dr David Fuller said passing this first interim analysis for DMX-200 was a key milestone.
“It demonstrates that DMX-200 is performing better than placebo in reducing proteinuria in a much larger cohort than our prior eight-patient Phase 2 study, and this validates our strategy and our prioritisation of this potentially valuable program in a disease where there are no FDA approved therapies,” Dr Fuller said.
“We now look forward to rapidly expanding this study, which will include recruiting children down to 12 years old as well as adults.”
It is expected that the full trial will include about 286 patients and is currently being conducted across multiple study sites in 11 countries.
The drug was identified using Dimerix’s proprietary assay, Receptor Heteromer Investigation Technology, which was developed at the Harry Perkins Institute of Medical Research.
DMX-200 was co-invented by UWA’s Director Biomedical and Health Innovation, Professor Kevin Pfleger, along with Dr James Williams and Liddy McCall.
Last year, UK-based Advanz Pharma acquired the rights to commercialise the clinical-stage drug DMX-200 in the European Economic Area, the UK, Switzerland, Canada, Australia and New Zealand.
