Dimerix Ltd Treatment for People With Rare Focal Segmental Glomerulosclerosis Disease Passes Endpoint In Phase 3 Study

Dimerix Ltd (ASX: DXB) has revealed the ACTION3 Phase 3 trial has successfully passed the first interim analysis using a proteinuria efficacy endpoint to treat FSGS.

FSGS is a rare disease that causes kidney scarring and can lead to end-stage kidney disease.

Currently, the Food & Drug Administration (FDA) has not approved an interventional therapy to treat FSGS.

The total FSGS market size is driven by around 220,000 FSGS sufferers across the seven major markets and attracts premium orphan drug pricing.

The opportunity exists for Dimerix to progress its novel DMX-200 intervention for the indication to market.

The company said the Phase 3 study showed that DMX-200 performed better than placebo in reducing proteinuria (using a statistical measure) in patients with focal segmental glomerulosclerosis (FSGS).

The cohort was significantly larger than the previous Phase 2 study.

Phase 3 studies

Phase 3 clinical trials follow phase 1 and 2 clinical trials.

The main focus of phase 3 trials is to demonstrate and confirm the preliminary evidence gathered in the previous trials that the drug is, a safe, beneficial, and effective treatment for the intended indication.

Passing this early interim analysis suggests a statistically significant and clinically meaningful result for the drug candidate in reducing proteinuria is possible.

Dr David Fuller; chief medical officer for Dimerix said of the results:

“It demonstrates that DMX-200 is performing better than placebo in reducing proteinuria in a much larger cohort than our prior 8-patient Phase 2 study.

This validates our strategy and our prioritisation of this potentially valuable program in a disease where there are no FDA-approved therapies.”

The next steps for Dimerix include expanding this study, which will include recruiting children down to 12 years old as well as adults.

With the success of the study, Dimerix should find investor support to expand its funding base via a capital raising.

 

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