Both investors and patients are lining the footpaths as the Aussie clinical-stage biotech reveals its first doses are already in the bloodstream in a highly anticipated Phase 3 study. 

DXB is trading about 6% higher around lunchtime on Tuesday (AEDT), on news the first interim analysis is due in March, with the company prepping the market for more updates  as patient dosing accelerates.

Reel it back a moment and by the end of 2021, Dimerix (ASX:DXB) – with increasing COVID-19 infections occurring around the world –  secured Australian ethics approval one of its key Phase 3 studies (dubbed CLARITY 2.0).


Combination dosing

This morning, the company informed the stock exchange the first patients have been dosed in India with a combination therapy which includes DMX-200 as part of the CLARITY 2.0 study.

The combination dosing is part of an ongoing strategic timetable which now looks to leverage the feasibility/Phase 3 study to test the safety and effectiveness of DXBs new treatment for respiratory complications associated with COVID-19.


Study update

The CLARITY 2.0 study is taking place across Australia and India and is led by Professor Meg Jardine, Director of the NHMRC Clinical Trials Centre at The University of Sydney, in collaboration with Professor Vivek Jha – Director of India’s George Institute.

Patient dosing in the study follows an extensive period of groundwork where the project leaders gained both regulatory and ethics approval to commence.


80, and then 600

An interim safety analysis will be carried out once the first 80 patients in India have received a dose, with results expected before the end of the March quarter.

The study will then look to accelerate dosing to enrol the full 600 patients that are experiencing symptoms from COVID-19, Dimerix said.

The primary endpoint will be an eight-point clinical health score measured on treatment day 14, as adapted from the categorical scale recommended by the World Health Organisation (WHO) for COVID-19 trials.

“Participants will be treated for up to 28 days with long-term outcomes of treatment assessed at 26 weeks,” Dimerix said.


A passage through India

It marks an exciting period of development for DXB, with its primary drug candidate included as part of a novel combination therapy to treat COVID-19 patients in India – the largest country in the world by population and a region where COVID-19 still poses major health risks with case numbers surging in some areas.

It follows on from the December headlines, when DXB secured the regulatory green light to kick on with the CLARITY 2.0 Phase 3 study in Australia.


Scientific rationale, unique and complementary

Dimerix’s approach to the study is “based on a clear scientific rationale, is unique and potentially complementary to others being investigated globally”, the company said.

Importantly, if effective in this study, the company says DMX-200 would likely “be effective against any strain as well as potentially other pneumonias with a common mechanism of action”.

To-date, antiviral medications have proved more successful if administered within 3-5 days of a patient catching the infection.

However, a key advantage of the DMX-200 is that it doesn’t rely on early identification and intervention – unlike most other drugs out there which need to get in the system as soon as possible to block the viral load spreading, Dimerix said.

“In contrast, DMX-200 does not rely on early inhibition of viral replication but aims to prevent the damaging immune response and lung flooding regardless of vaccination or antiviral treatment,” the company said.

“As such, DMX-200 may be beneficial for patients with a wide range of respiratory diseases in addition to the various COVID-19 variants.”


Irons in the Omicron fire

The CLARITY 2.0 study is one of two international medical studies, along with the REMAP-CAP study, where Dimerix is assessing the effectiveness of DMX-200 in the treatment of COVID-19.

“Dimerix proactively supports both studies driven by the REMAP-CAP and CLARITY 2.0 teams in providing them information for the regulatory submissions and in supplying DMX-200 to the study sites,” it said.

The company “looks forward to reporting on progress and as key milestones are met”.

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.