Dimerix gets $8.9 million R&D tax rebate to advance Phase 3 FSGS kidney disease trial
Health & Biotech
Health & Biotech
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Dimerix Pharmaceuticals will have more cash in its pocket to progress its Phase 3 trial into Focal Segmental Glomerulosclerosis (FSGS) after receiving a~$9 million Research and Development (R&D) Tax Incentive rebate for FY23.
Dimerix Limited (ASX:DXB) is a biopharmaceutical company with late-stage clinical assets in inflammatory diseases.
DXB’s global Phase 3 trial, known as ACTION3, is investigating its lead compound, DMX-200, in patients with FSGS kidney disease.
DMX-200 is a chemokine receptor (CCR2) antagonist administered as a single capsule twice a day to patients already receiving the standard of care treatment for hypertension and kidney disease, an angiotensin receptor blocker (ARB)-.
In addition to the market exclusivity that comes with being a new orphan drug, DMX-200 is protected by granted patents in various territories until at least 2032, with patent applications submitted globally that may extend patent protection to 2042 if granted.
The multi-centre, double-blind, placebo-controlled trial is being conducted at more than 70 clinical sites in 11 countries.
The trial features two interim analysis points along the way to assess proteinuria and kidney function, aiming to support a potential accelerated marketing approval.
The last patient data collection for the Phase 3 trial is set for February 26, 2024, with the first interim data expected around March 15, 2024.
Positive results in the first interim analysis would signify a clinically and statistically meaningful difference between drug and placebo, leading to the continuation of the trial.
Initially focusing on patients aged 18 to 80 on stable doses of ARBs, the trial will be expanding to include patients aged 12 to 80 following a successful interim analysis outcome.
FSGS, a rare kidney disease with no approved treatment, causes irreversible kidney scarring and often leads to end-stage kidney failure.
Even after kidney transplantation, around 60% of patients experience recurrent FSGS. The disease affects both adults and children as young as two years old, but there are currently no approved drugs specifically for FSGS, resulting in limited treatment options and a bleak outlook.
DMX-200 has Orphan Drug Designation from the US FDA, EMA, and UK, enabling potential fast track of commercialisation upon successful results.
The FSGS market is estimated to exceed US$3 billion by 2032 due to the substantial patient population and premium orphan drug pricing.
The R&D Tax Incentive program is the Federal Government’s key mechanism to stimulate Australian industries investment in R&D.
It provides a tax offset equal to the entity’s company tax rate plus an 18.5% premium for eligible entities with an aggregated turnover of less than $20 million per annum.
DMX Research and Development (R&D) Tax Incentive rebate for FY23 amounts to $8,934,637.
DMX CEO and managing director Dr Nina Webster says following receipt of the funds the company will repay the outstanding Radium Capital R&D loan balance of ~$2,842,500, plus associated fees and interest.
“This rebate will be applied to progressing the company’s lead global Phase 3 clinical program in FSGS kidney disease patients, as we approach the first data analysis outcome in March 2024,” she says.
“We greatly appreciate the support of the Australian Government with this invaluable incentive, as Dimerix advances DMX-200 towards commercialisation.”
“We look forward to updating the market on these activities in due course.”
This article was developed in collaboration with Dimerix Pharmaceuticals, 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.