The ACTION3 Phase 3 clinical trial conducted by Dimerix will study the effects of its lead drug, DMX-200, on patients with FSGS kidney disease.
Aussie clinical stage biotech Dimerix (ASX:DXB) has completed a significant milestone in its ACTION3 Phase 3 pivotal clinical trial, following the recruitment of the first patient.
This ACTION 3 Phase 3 study is a pivotal clinical trial of Dimerix’s lead asset DMX-200, for the treatment of focal segmental glomerulosclerosis (FSGS) disease, a rare type of kidney disease.
The trials will be performed across 75 sites in 12 different countries globally, with ethics and regulatory submissions already made in all 12 countries, including an open IND in the US.
All activated sites are currently proactively screening for suitable patients, with the first interim results anticipated in the first half of 2023.
“This is a significant step forward for Dimerix with recruitment of the first patient into our key Phase 3 ACTION3 FSGS kidney clinical trial,” says Dr Nina Webster, CEO of Dimerix.
“We also expect first dosing in the trial to commence imminently.”
ACTION3 trial objectives
The trial will have two interim analysis points that are designed to capture evidence of proteinuria and kidney function (eGFR slope), aimed at generating sufficient evidence to support accelerated marketing approval.
The potential for accelerated marketing approval is the percent change in protein in the urine (proteinuria) from baseline to Week 35, following treatment with DMX-200 compared with placebo.
Part 1 of the trial will conclude after that first interim analysis, once 72 patients have completed 35 weeks treatment, and is expected to occur in the first half of 2023 (subject to recruitment).
The trial will then continue into Part 2, where patients recruited will need to demonstrate a minimum of 6 weeks stable dosing of an angiotensin receptor blocker (ARB) prior to dosing with DMX-200 or placebo.
Once the ARB dose is stable, patients, aged 18 to 80 years, will be randomised to receive either DMX-200 (120 mg capsule twice daily) or placebo.
FSGS is a rare disease with no existing registered treatment option, which cost US$55 billion per annum to the US healthcare system in 2021 alone.
“The potential commercial opportunity for Dimerix in this space is very material, given over US$55 billion is estimated to have been spent on end stage renal failure in the US Healthcare system alone in 2021,” Dr. Webster explains.
“The US Government has issued incentives for physicians to delay patient progression to renal failure as a priority,” she adds.
Dimerix’s patents
Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe, as well as the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK, for the treatment of FSGS.
These designations provide companies with a regulatory pathway to help bring new drugs to market faster.
In addition to its existing granted patents for DMX-200, Dimerix has also filed two new global patents covering the use of DMX-200 as a “Treatment of Inflammatory Diseases”, and as “Compositions Comprising a Chemokine Receptor Pathway Inhibitor”.
If granted, it will extend and broaden the protection for DMX-200 from 2032 under the existing granted patents until at least March 2041 and January 2042 respectively.
Dr. Webster explains that DMX-200 could potentially make a lot of difference in the lives of patients with FSGS disease.
“If successful, our drug candidate could make a huge difference globally to patients with this illness and given we have orphan drug designation status, a potential fast track to commercialisation is available – highlighting the compelling nature of this trial for the company,” she says.
Apart from the FSGS Phase 3 program, Dimerix is also progressing multiple assets in the clinic including diabetic kidney disease, chronic obstructive pulmonary disease (COPD), and COVID-19 programs.
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.
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