The EMA confirmed that DXB’s study design meets the criteria for potential accelerated approval of its treatment solution to FSGS kidney disease.

Clinical-stage biopharmaceutical company Dimerix (ASX:DXB) has been busy working with global regulators on the study design of its Phase 3 clinical trial program for the treatment of FSGS (Focal Segmental Glomerulosclerosis) kidney disease.

And the company took another important step forward this morning, with confirmation from the European Medicines Agency (EMA) that its design meets the criteria for potential conditional/accelerated approval in the event of a successful trial result.

Dimerix announced it has received written correspondence from the EMA which defined the primary end-points for conditional approval of DXB’s proprietary DMX-200 treatment, based on clinically relevant outcomes for key indicators such as levels of protein in the urine (proteinuria) and its relationship to kidney function.

DXB said the EMA’s ruling aligns with interim work it has already completed on the study, which was designed to “capture evidence of proteinuria and kidney function during the study”.

As a result, the parameters of the study are now “aimed at ensuring regulatory agencies will have sufficient evidence to assess DMX-200 for conditional/accelerated marketing approval”, Dimerix said.

 

Key details

Just as importantly, the EMA also confirmed that angiotensin receptor blockers (ARBs) are “recognised as the standard of care in Europe and are acceptable as the background therapy to DMX-200 for FSGS patient”.

That marked a key regulatory development for Dimerix’s DMX-200 treatment, which works together with ARBs with the aim of providing improved patient outcomes.

“This was critically important to the program, given FSGS is not an approved indication for ARB usage in Europe,” Dimerix said.

 

Global opportunity

FSGS is a rare kidney disease that affects around 210,000 people globally each year.

It attacks the kidney’s filtering units where blood is cleaned, leading to irreversible scarring. On average, an FSGS diagnosis results in kidney failure within five years.

In that context, Dimerix’s DMX-200 treatment has been granted orphan drug designation in both the US and Europe – defined as a potential solution to a health problem where no other treatment currently exists anywhere in the world.

Orphan drug designation provides the regulatory framework to bring drugs to market faster with lower costs, and also allows for longer exclusivity periods.

Conditional approval from the EMA is the equivalent of accelerated approval for orphan drug treatments by the US FDA.

Having received the go-ahead from the EMA, Dimerix has also scheduled a virtual meeting with the FDA to confirm that the study design endpoints also meet the criteria for accelerated approval in US markets.

 

Timeline

Once confirmation from the FDA is received, Dimerix will commence recruiting patients and initiating clinical test sites across global jurisdictions – a process that’s expected to kick off in the next couple of months.

In preparation for the study, Dimerix has appointed the NYSE-listed IQVIA Holdings as the lead contract research organisation (CRO).

IQVIA is the largest global CRO and has recent experience running late-stage clinical studies for FSGS treatments.

Dimerix CEO Nina Webster said the latest developments mark a key step forward for the company as it pursues a much-needed treatment solution to the ongoing threat posed by FSGS.

“The clinical data to date suggest that treatment with DMX-200 may indeed result in clinically meaningful improvements in kidney function, when added to the standard of care in patients with FSGS,” Webster said.

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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