Special Report: Melbourne biotech company Dimerix (ASX:DXB) expects to receive readouts on three phase 3 studies in the near term – any one of which could be transformative for the $40 million company.

It’s been a big year for Dimerix, which has managed to weather the COVID pandemic without major corporate disruption to either its clinical trials or its laboratory research.

Thanks to precautions the company took in February, Dimerix managed to keep its clinical trials going throughout the pandemic, and while its corporate office in Melbourne was hit by Victoria’s lockdowns, its use of laboratories in Western Australia managed to continue its work.

As the virus raged in 2020, two sets of independent researchers have chosen to investigate Dimerix’s lead drug candidate as a possible COVID-19 respiratory treatment, research the company expects could bear fruit in the middle of next year.

“It’s been a massive year – and 2021 has the potential to be even bigger, from a value proposition,” says Dimerix chief executive and managing director Nina Webster.

“There’s a lot happening with Dimerix at the moment. We started 2020 in two Phase 2 studies, and we are finishing the year in three Phase 3 studies.”

The company expects to see results from both the REMAP-CAP and CLARITY studies in mid-2021, both of which have included Dimerix’s chemokine receptor (CCR2) blocker DMX-200 in large-scale assessments of COVID-19 respiratory treatments.

Because those phase 3 studies are investigator-initiated, Dimerix isn’t on the hook for the significant cost of a large-scale, global clinical trial.

(The Australian government’s Medical Research Future Fund did award Dimerix $1 million to support DMX-200’s inclusion in the REMAP-CAP study, and the company is providing DMX-200 and matched placebo study medication for the NHMRC Clinical Trials Centre’s  CLARITY study).

But if either study shows DMX-200 is safe and effective treating seriously ill COVID patients, Dimerix could use that data to apply for an emergency use authorisation for the drug.

It could also gain valuable insight about using DMX-200 to treat acute respiratory distress syndrome (ARDS) associated with other infections such as pneumonia and influenza.

“We get the data, but it’s essentially supported and funded,” Webster says.

DMX-200 is a capsule that contains a new drug, repagermanium, that is synergistically administered to patients taking an existing drug, an angiotensin receptor blocker. DMX-200 works as a potent anti-inflammatory, and researchers think it could work to quell the “cytokine storm” of lung inflammation responsible for so many COVID deaths.­­­

And beyond the financial impact, there’s also the possible social impact of coming up for a treatment for a disease that’s stricken over 75 million people across the world.

“If it works, there’s likely to have a big impact on quality of life, beyond hospitalisation, having reduced the lung damage caused by COVID-19,” Webster says.


FSGS study upcoming

The company also expects to next year begin a phase 3 trial of using DMX-200 to treat a rare kidney disease known as FSGS (focal segmental glomerulosclerosis), with an interim readout from the data expected in 2022.

There are no other global studies for FSGS currently being initiated, meaning that Dimerix won’t have to compete with other clinical trials for patients, Webster says.

“In an orphan indication, that’s really important,” she said.

Treatments for kidney disease have been actively traded in the pharmaceutical industry, with the value of the average deal exceeding $US500 million ($650 million) plus royalties.

“They are all highly lucrative potential opportunities,” Webster says.

While Dimerix is also working on research that will take longer to possibly pay off – such as DMX-200 in diabetic kidney disease, which also demonstrated a positive outcome in a recent phase 2 study, and  its drug candidate DMX-700, being investigated as a possible treatment for constructive obstructive pulmonary disease (COPD)– Webster is excited about the near-term possibilities.

“There are three shots on goal, all in phase three studies,” she says.

“It’s going to be a big year.”

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.