Dimerix to move forward with DMX-200 after phase 2 clinical trial
Health & Biotech
Health & Biotech
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Special Report: Dimerix plans to further explore the potential of DMX-200 to treat kidney diseases following the completion of a positive and informative phase-2 trial.
Dimerix (ASX:DXB) says it will progress with research on its chemokine receptor (CCR2) blocker DMX-200 after a phase-two clinical trial found it had positive effects in diabetic kidney patients with the worst prognosis.
While the study didn’t show a statistically significant difference between DMX-200 and placebo across the full 40-patient study cohort, it did help the 26 patients who had the highest levels of a protein that is a key indication of kidney damage.
Those 26 patients who had levels of albuminuria greater than 500mg/g saw an 18 per cent reduction in that protein on DMX-200 compared to placebo, which was a statistically and clinically significant result.
Nearly two thirds of the 26 patients with higher starting albuminuria levels showed a statistically significant reduction, and 56 per cent achieved a greater than 25 per cent reduction.
The rigorous study used a crossover design, meaning each of the 40 patients received both 12 weeks of DMX-200 and placebo, with a six-week “washout period” between the dosing.
The study also showed that DMX-200 was safe and well-tolerated, with no serious adverse effects recorded in the study.
Associate Professor David Packham, a kidney specialist with the Melbourne Renal Research Group, said that a possible confounding factor in the study was that patients on the placebo actually experienced a 12 per cent reduction in albuminuria, something investigators would be trying to explain in the weeks to come.
“We recognise that many of these patients would have been on other medications,” he told analysts in a conference call.
It also could have been a “legacy effect” from the DMX-200, which the company should be able to discern as investigators analyse the data further.
“The potential for a legacy effect is intriguing, especially as early data analysis suggests a similar effect in the recently reported ACTION FSGS trial, and I look forward to the outcomes of the additional data analysis,” Packham said.
Dimerix will assess the complete results prior to help plan and move forward with more research on using DMX-200 to treat diabetic kidney disease once that data analysis is complete, although in contrast to the planned FSGS study, a phase 3 study in diabetic kidney disease would require a partnership with a larger pharmaceutical company.
The company recently reported results of its phase 2 clinical trial of DMX-200 to treat focal segmental glomerulosclerosis (FSGS), a serious and rare disease that attacks the kidney’s filtering units.
As previously reported, DMX-200 has been awarded orphan drug status for FSGS, giving it accelerated regulatory approvals and tax breaks.
Dimerix chief executive and managing director Dr Nina Webster says the diabetic kidney study was the third study conducted by Dimerix that showed efficacy in a group of patients with an active inflammatory disease.
She added that it was “a very positive outcome and supportive of our plan to progress DMX-200 into a phase 3 clinical study in FSGS in the first half of 2021, in parallel to partnering discussions and ultimately further testing in later stage diabetic kidney disease patients”.
“The collective phase 2 data is invaluable in informing the design and execution of our single phase 3 registration study in FSGS and further increases our confidence that DMX-200 will prove a valuable therapeutic option to patients suffering FSGS and who currently have no approved or effective medication.”
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.