Dimerix to launch diabetes-related disease trial in Australia; FDA interest persists
Dimerix (ASX:DXB) executes agreement with Canberra-backed centre to launch DMX-200 trial
Source: Image of a model figurine of a human kidney
Mentioned
KEY POINTS
- Dimerix to launch kidney disease trial using patent DMX-200 product in Australia starting later this year
- DMX-200 was awarded Investigational New Drug status by the US FDA earlier this year on the back of promising 2020 results
- Company expects diabetes-related kidney diseases to grow by 54% by 2040 as disease impacts younger age groups; aging population
Diabetes-focused biotech player Dimerix (ASX:DXB) has today executed an agreement with the Australian Centre for Accelerating Diabetes Innovations (ACADI) to conduct a clinical trial of its oral medical product DMX-200 in diabetic kidney disease patients.
The company's DMX-200 product acts as an inhibitor of a compound in the body which attracts inflammatory cells into the kidneys, called chemokine receptor CCR2. Patients ingest 2x 120mg doses daily.
DMX-200 recently won key approvals from the FDA to conduct trials in the US with the product awarded often sought-after Investigational New Drug (IND) status; the designation ultimately affords companies trialling new products fast-track status through the FDA approvals circuit.
Patents for the product are also already lodged in Canada, China and Japan.
(Source: Dimerix) Dimerix believes a US$1.1bn market already exists, set to grow larger
ACADI backed by Canberra
ACADI, with which Dimerix has today executed an agreement for DMX-200 diabetes studies in Australia, is a group established by Canberra with funding from the Translation Research Accelerator Program delivered by partner organisation MTPConnect.
ACADI prioritises the treatment of diabetic kidney disease; it chose DMX-200 for further trials based on the successful results of a 2020 study.
The trial to be launched on the back of the agreement today will be ready by the end of the year, Dimerix says, and is to carry on for up to two years with an interim analysis to be delivered in the short-term.
Diabetes forecast to become more common
Dimerix will work alongside ACADI's associate professor Elif Ekinci from UMelb, who worked on the 2020 study.
Dimerix is targeting diabetics products given that it lends credence to data suggesting diabetes incidence will grow by 54% on current prevalence rates into 2040.
The key drivers behind this upward forecast are the impacts of an aging (US) population, rising rates of obesity, and the increasing incidence of diabetes in younger age groups.
There is currently no known cure for diabetic kidney disease.
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