This ASX biotech is one of the few running a Phase 3 clinical trial against COVID-19, and it’s firmly on track to proceed
Health & Biotech
Health & Biotech
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Shareholders of Dimerix (ASX:DXB) got an early Christmas present with the company telling them its Phase 3 clinical trial testing its DMX-200 drug against COVID-19 pneumonia respiratory complications in Europe was on track.
The study (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.
The company 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.
At the moment the majority of patients (485) enrolled are in the UK, but the company is hoping to add additional study sites across Italy and France.
The progress with the REMAP-CAP study comes at a pivotal point in the pandemic as the omicron variant overtakes delta as the world’s most dominant COVID-19 strain.
While research to determine if COVID-19 vaccines are effective against omicron is ongoing, Dimerix is optimistic that if DMX-200 is effective in COVID-19 respiratory complications from any particular strain, it would likely be equally effective against any other strain of COVID-19.
The company also believes DMX-200 might be able to fight other infections such as influenza and pneumonia, which would provide an opportunity stretching beyond the current pandemic.
REMAP-CAP is not the only Phase III trial Dimerix currently has in the pipeline.
Phase III is typically the last hurdle – at least from a clinical perspective – that drugs have to pass before being commercialised. It’s typically used to assess efficacy after safety parameters have been established.
While only a handful of ASX companies are currently operating or have concluded Phase 3 trials, Phase 3 success is often a major catalyst for a biotech company and its investors.
A good recent example was Neuren Pharmaceuticals (ASX:NEU), which has more than doubled since its successful Phase 3 trial against Rett Syndrome.
Dimerix is running another Phase 3 trial against COVID-19 (CLARITY 2.0) which will be conducted across Australia and India.
Approval is currently being sought in Australia but it has already begun recruiting patients in India and once the first 80 have been enrolled, an interim safety analysis will be conducted.
FSGS affects 210,000 people globally per year and there are no treatments approved. But Dimerix’s provides hope to researchers, clinicians and patients hope that an effective treatment may not be too far away – especially having reached the Phase III point.
Dimerix expects to enrol its first patients this quarter and is well capitalised to proceed after major investors backed its FSGS treatment with a marquee funding round this year.
The company completed a $20 million placement in September, which was followed up by a $4 million Share Purchase Plan in October.
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.