Support from the FDA gives DBX additional clarity as it builds out globally significant Phase 3 trials in the second half of this year.

Biopharmaceutical company Dimerix (ASX:DXB) continues to attract the support of global regulators, as it moves towards Phase 3 trials for the use of its patented DMX-200 drug in the treatment of FSGS kidney disease.

In an important announcement this morning, the company advised that the US Food & Drug Administration (FDA) has confirmed that its Phase 3 study design (with interim analysis) is appropriate to support the potential for accelerated approval in the US market.

The FDA decision follows a similar accelerated approval decision by the European Medicines Agency (EMA) last month, which is now under review by the MHRA (the UK health regulator).

 

Robust framework

“The closely aligned advice from both the FDA and the EMA provides confidence in the study design and appropriate endpoints for marketing approval,” Dimerix said.

Shares in the company rose again today in morning trade, and the stock has now risen by around 25% since the start of July.

The meeting minutes from the FDA provided clarity around its support for the primary endpoints in Dimerix’s study design, which is targeted around protein in the urine (proteinuria).

Specifically, the FDA confirmed that “improvement in proteinuria was an acceptable surrogate endpoint for accelerated approval, with sufficient demonstration of the relationship to kidney function”.

Accelerated approval is a unique regulatory application for drugs such as DMX-200 that have successfully achieved ‘orphan’ designation, as a potential solution where no other treatment currently exists.

FSGS (Focal Segmental Glomerulosclerosis) 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 and typically results in kidney failure within five years, with no known existing remedy.

Dimerix CEO Nina Webster said the FDA’s support of reduced proteinuria levels as a surrogate for accelerated approval was “particularly encouraging”.

The FDA also confirmed that Dimerix’s approach to statistical analysis as part of the clinical trial design was also acceptable.

In reaching that conclusion, the FDA reviewed a number of analytics procedures Dimerix has designed to “capture evidence of proteinuria and kidney function during the study”.

Looking ahead, Webster said support from global regulators gives the company more clarity and confidence as it builds off last year’s Phase 2 trials and moves towards commercialisation.

“The positive Phase 2 clinical data reported in 2020 suggests 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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