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Dimerix crucial Phase 3 trials advance, deliver multi-million R&D tax refund

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The taxman has given Dimerix a financial boost as it continues to advance Phase 3 trials into treatments for Covid-19 and a rare kidney disease.

Clinical stage biopharma Dimerix (ASX:DXB) has received an almost $3.7 million research and development (R&D) tax incentive refund for expenses from the 2021 financial year.

The R&D Tax Incentive program is jointly administered by the Australian  Taxation  Office  and  AusIndustry allowing companies to receive up to 43.5%  refundable tax offset of eligible expenses associated with R&D initiatives.

Dimerix CEO and Managing Director Dr Nina Webster said FY21 was a pivotal year for the company in R&D.

“We continued to deliver on our strategic goals as we expanded our programs to include supporting two global Phase 3 clinical studies to develop a product that may help in treatment of COVID-19 patients, as well as progress our renal program into a phase 3 clinical study and advance longer-term  opportunities,” Webster said.

“The Australian  government’s  support  of  domestic  research  and  development  is  invaluable  and  plays a critical role in supporting companies like Dimerix.

“We look forward to updating the market on these activities in due course.”

 

Treatment for rare kidney disease

Dimerix has progressed its Phase 3 study in the use of lead drug candidate DMX-200 as an adjunct therapy in the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease.

Dimerix has obtained ethical and/or regulatory approval for the trial in multiple countries including Australia, Argentina, Brazil, Denmark, France, Hong Kong, New Zealand, South Korea, Spain, Taiwan and the United Kingdom.

The company has now built out a global Phase 3 study across 70 sites in 12 countries after phase 2a trials demonstrated encouraging safety and efficacy measures.

Around 210,000 people are diagnosed with FSGS globally and there are currently no approved therapies, which gives DXB a potential multi-billion-dollar addressable market.

 

Covid-19 studies

DMX-200 has also been part of two studies for a treatment solution for COVID-19.

Endorsed by the World Health Organisation (WHO) and funded by the European Union, the REMAP-CAP study tested a treatment solution for respiratory problems associated with COVID-19. The study has recruited more than 750 patients across the UK and Europe, and interim data analysis is currently underway.

Dimerix is also involved in the CLARITY 2.0 study for a COVID-19 treatment solution, recruiting 600 patients across Australia and India.

The use of DMX-200 in both studies is to help reduce damage from inflammatory cells by blocking their signalling and limiting subsequent onset of fibrosis. As such, if effective in these COVID studies, DMX-200 may well be effective in other infection related pneumonias, including influenza, as well as the different strains of the infection.

While vaccines are part of the global health response to the pandemic, solutions to also reduce symptoms associated with COVID-19, and other respiratory complications including pneumonia, will also been needed for years to come.

The first run of top-line data results for both studies are expected this year.

The R&D tax rebate adds to Dimerix’s financial stability. It is well funded after a marquee capital raise last 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.

Categories: Health & Biotech

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