The launch of CLARITY 2.0 in Australia follows on from its momentum in India, where the study has already gained key regulatory approval.

ASX biotech Dimerix (ASX:DXB) says the global CLARITY 2.0 study into the use of its proprietary DMX-200 drug in the treatment of COVID-19 is just one of many exciting development pathways for the company.

On that front, DXB provided another key update on Friday with news that the study is expanding into Australia, via an agreement with the NHMRC Clinical Trials Centre (CTC) at the University of Sydney.

Led by Sydney Uni professor Meg Jardine, the study last month received protocol approval from The Central Drugs Standard Control Organization (DCGI) in India, where multiple clinical sites have already been initiated.

With its launch into Australia, an initial six sites in NSW, Victoria and Queensland will begin recruitment for the feasibility/Phase 3 study, once regulatory and ethics approval is received.

 

Crucial treatment

For the CLARITY 2.0 study, Dimerix’s DMX-200 drug – a CCR2 inhibitor — is being tested as a treatment of respiratory complications associated with COVID-19.

While vaccination rates in Australia are rapidly climbing, it’s expected that a material percentage of the population will remain susceptible, either through lack of vaccine uptake, or an insufficient vaccine response, Dimerix said.

In that context, the testing and approval of additional treatments will play a key role in negating the disease, both from an individual and a public health standpoint.

“A safe, affordable, and effective oral treatment would be a huge advance in the fight against COVID-19,” Jardine said.

“Improving treatments for patients hospitalised with COVID-19 remains crucial. We are delighted to be part of a team working towards a treatment that could benefit COVID-19 patients globally.”

 

CLARITY 2.0

With pending access to the domestic market, the CLARITY 2.0 study will now look to recruit 600 patients across Australia and India for the Phase 3 study.

Dimerix’s drug candidate, DMX-200, works to block a particular signalling protein that is involved in inflammation and is given to patients also taking an Angiotensin Receptor Blocker (ARB).

And the study will test whether the treatment with DMX-200 results in more optimised outcomes for patients suffering an inflammatory response to COVID-19 versus placebo and versus those on an ARB alone.

CLARITY 2.0 is a prospective, multi-centre, randomised, double blind, placebo controlled study.

The primary endpoint will be an 8-point clinical health score measured on treatment day 14, in accordance with the categorial scale recommended by the World Health Organisation for these kinds of trials.

The study is based on a “clear scientific rationale, unique and potentially complementary to others being investigated globally”, Dimerix said.

And importantly, if proven effective, the treatment “would likely be effective against any strain (of COVID-19), as well as potentially other pneumonias with a common mechanism of action”, the company added.

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.

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