Christmas has come early for Dimerix with Australian ethics approval granted for a Phase 3 clinical trial of its DMX-200 drug in COVID-19 patients with pneumonia respiratory complications.

As the latest Omicron variant fuels COVID-19 cases numbers Australia-wide, clinical stage biopharma Dimerix (ASX:DXB) has announced its CLARITY 2.0 trial has been given the go ahead by the Research Ethics and Governance Office Ethics Committee.

The CLARITY team anticipates initiating recruitment across New South Wales, Victoria, and Queensland in January just as case numbers and hospitalisations forecast to rise significantly across Australia, which may influence recruitment rates.


Expansion of Phase 3 studies

Dimerix’s DMX-200 therapy is designed to reduce damage from inflammatory immune cells  by blocking signals and limiting subsequent movement, essentially alleviating respiratory  complications associated with COVID-19.

The novel drug is being studied as part of two different investigator-led Phase 3 studies in  COVID-19 patients with respiratory complications, both of which are actively recruiting.

 The CLARITY 2.0 study has already been approved and is open for recruitment in India.

An aggregate of 600 patients across both India and Australia are now expected to be recruited into the study.

The NHMRC Clinical Trials Centre (CTC) will be the local sponsor in Australia, led by Professor Meg Jardine.  Additional countries that could recruit patients for the study are also being investigated.

DMX-200 was earlier selected for inclusion in the global REMAP-CAP study of respiratory diseases.

Dimerix announced this week the REMAP-CAP study of DMX-200 in patients with respiratory complications from COVID-19 in Europe was on track.

REMAP-CAP has now enrolled a total of 662 patients, which is more than triple the total number of patients in August and is also up ~39% in under four weeks.

Dimerix also received positive feedback from the REMAP-CAP Data Safety Monitoring Board (DSMB) review. The review found no concerning safety issues and recommended the study should continue to enrol patients.


Likely broad effectiveness

Antiviral   medications   are   typically   effective   at   preventing   damage   caused   by   a   virus  when  administered within 3-5 days of infection as the treatment aims to minimise viral replication.

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.

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

The company is also running a Phase 3 clinical study of DMX-200 in patients with Focal Segmental Glomerulosclerosis (FSGS), which is a rare kidney disease.  FSGS leads to end-stage kidney failure and is currently without approved pharmacologic treatment.


More government funding

Dimerix has received an additional $100k fund from the Australian government’s Medical Research Future  Fund (MRFF) via its Biomedical Translation Bridge (BTB) program.

These funds are in addition to the previously awarded $1 million grant the company received from the same program, announced in September last year.

The funds will be used to expedite the commercialisation of DMX-200 into commercialisation.

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.