Dimerix: Kidney disease drug trial misinterpreted
Health & Biotech
Health & Biotech
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Special Report: Dimerix chief executive Dr Nina Webster says that Phase II study testing how well its drug candidate DMX-200 worked to treat diabetic kidney disease did “exactly what it’s designed to do”.
Attention ASX shoppers – there are bargains to be found in aisle two.
Dimerix shares (ASX:DXB) are trading for about a third of their value from earlier this month after announcing a Phase II clinical trial of the Melbourne biotech’s drug candidate DMX-200 resulted in positive outcomes whilst not meeting its primary endpoint in 40 patients with diabetic kidney disease with statistical significance.
But Dimerix chief executive and managing director Dr Nina Webster says the trial was not a failure at all.
“It’s Phase II, it’s done exactly what it’s designed to do,” she told Stockhead on Friday.
Phase II studies are designed to inform the design of Phase III studies, and just because the study did not show statistical significance in its primary endpoint doesn’t mean that DMX-200 is ineffective in treating diabetic kidney disease, Dr Webster notes.
In fact, the study suggested that DMX-200 actually was effective in patients with early kidney disease diagnosis, showing a statistically and clinically relevant association between the drug treatment and improvement in key protein levels in the 26 patients with only marginally higher protein levels in the urine.
The results are consistent with prior studies showing that patients with higher starting levels of albuminuria – a marker of kidney damage – showed statistically significant improvement in their levels of the blood protein while on the drug.
Kidney disease is a progressive disease; you cannot regrow your kidney. Therefore kidney function will decline over time, Dr Webster notes.
“The difference between 30 mg/mmol and 57 mg/mmol is small on the scale of predicted kidney decline. Many patients may not even be diagnosed with kidney disease until they have over 57mg/mmol albuminuria, and for others it can be a difference of just a few months as unfortunately every patient will eventually end up with more protein spilling into the urine, thus has no impact on the potential market for FSGS and very little impact on the potential market for diabetic kidney disease.”
The drug is a chemokine receptor (CCR2) blocker that Dimerix believes may work to lessen the inflammatory response in patients, potentially delaying end-stage kidney failure and extending life.
Further analysis of the study results are expected in a few weeks, which will inform the company on the path forward and potential clinical study design for diabetic kidney disease.
There’s a lot at stake – the diabetic kidney disease market was estimated at $US5.8 billion ($8.2 billion) in 2018, with market growth expected to grow by 5.1 per cent a year. There are only a few players producing the ARBs receptor blockers that are the current standard of care.
In the meantime, Dimerix is moving forward on its plan to progress DMX-200 into a Phase III clinical study to treat focal segmental glomerulosclerosis (FSGS), a serious and rare disease that attacks the kidney’s filtering units.
With no approved treatment available anywhere for FSGS, DMX-200 has been awarded orphan drug status for FSGS, giving it accelerated regulatory approvals and tax breaks.
Dimerix has also received $1m from the Federal Government to include DMX-200 in a global initiative testing treatments for COVID-19.
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.