CLARITY 2.0 study could unlock ‘exciting’ potential of Dimerix drug candidate DMX-200 as a COVID-19 treatment
Health & Biotech
Health & Biotech
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Special Report:The lead investigator of an international study evaluating COVID-19 treatments says Dimerix (ASX:DXB)’s DMX-200 drug candidate has the potential to work synergistically with a well-established class of pharmaceuticals to quell inflammation.
Biotech company Dimerix (ASX:DXB) is on track in the exciting new study to test the effectiveness of its DMX-200 as a treatment option for COVID-19.
The 2.0 CLARITY (Controlled evaluation of Angiotensin Receptor Blockers for COVID-19 respiraTorY disease) clinical trial is expected to begin dosing patients soon in India, where as many as 13,000 people a day are still being diagnosed with the respiratory ailment.
Lead investigator Professor Meg Jardine, a nephrologist and professor of medicine at the University of Sydney, says the study will begin enrolling the first 600 COVID-19 patients as soon as it receives ethics approval.
The CLARITY 2.0 study complements another already underway, looking at the efficacy of angiotensin receptor blockers (ARBs) to treat COVID-19.
COVID-19, Prof Jardine explains, appears to hijack the body’s renin-angiotensin system — tilting it towards inflammation and fibrosis.
“That might be why it has been so devastating in the lungs of some people, because it’s taking away that natural balance,” she says.
ARBs may even help to prevent or reduce viral entry into cells in the first place.
ARBs such as Avapro (irbesartan), Cozaar (losartan) and Benicar (olmesartan) have been used for about three decades to treat illnesses such as high blood pressure, heart failure and diabetic kidney disease.
Dimerix’s drug candidate, DMX-200, works to block a particular signalling protein that is involved in inflammation, Prof Jardine says.
“The exciting thing about DMX-200 is that it works in companion with the ARB,” Prof Jardine says. “The ARB blocks an early step in a cascade of inflammation, and then the DMX-200 acts further downstream, mopping up other processes that may have escaped the ARB.”
“So, the two together could work better than either one on its own.”
Synergies have already been observed with DMX-200 and ARBs in clinical trials evaluating the drug combination to treat diabetic kidney disease and in a rare kidney disease known as FSGS, or focal segmental glomerulosclerosis.
Many systems in the body operate by using multiple steps that can add up to a “cascade effect” and doctors have often found blocking a system at multiple points is more effective than just “hammering a single point in a pathway,” Prof Jardine said. For example, most patients who have an organ transplant are on three different medications to stop the body’s rejection systems – and they all stop it in different ways.
As a scientist, Prof Jardine is cautiously optimistic when talking about potential of DMX-200 taken together with an ARB.
“We know from the work in chronic kidney diseases that this combination looks promising. We won’t know if it is going to work in COVID-19 until we actually test it in that setting – so that’s why this trial is so important.”
“The most important thing, always, is to answer the scientific question.
“Of course, I hope it will be successful — the world needs treatments for COVID-19.”
Vaccinations are the most important line of defence, but there is clearly a need for multiple strategies for dealing with the novel coronavirus, Prof Jardine says.
India has had over 10 million coronavirus cases with more than 150,000 deaths – a tally that is only surpassed by the United States, Brazil, and Mexico.
The National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, which Prof Jardine directs, is collaborating with fellow nephrologist Professor Vivek Jha and his team at The George Institute, India.
If the trial is successful, Dimerix has pledged fair and ethical supply of DMX-200 within India in line with industry standards.
“That to me, and my colleagues, was a really important consideration — that there’s a commitment to make the drug available in the country where the trial is being conducted,” Prof Jardine said.
There are potentially broader benefits. Some of the research stimulated by our need to understand COVID-19 is suggesting that the renin angiotensin system may play a role in acute respiratory illnesses more generally. If ARBs and DMX-200 are beneficial for COVID-19, the next question will be to assess their role in other respiratory settings.
The study results may have implications not just for COVID-19 but for other respiratory illnesses such as influenza.
The data could be collated as part of an application for an emergency use authorisation that would bring the drug to market quicker – a potentially huge development for Dimerix.
Prof Jardine said she expected to receive results from the study sometime in 2021.
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.