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Dimerix Says Phase 3 Clinical Trial Data Review Shows Over 90% Statistical Power to Detect Proteinuria Treatment Effect; Shares Reach Two-Year Low

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Dimerix (ASX:DXB) said an external statistical blinded review of the data from the ACTION3 phase 3 clinical trial, evaluating its DMX-200 drug candidate in patients with focal segmental glomerulosclerosis, confirmed that the study had an over 90% statistical power to detect the treatment effect for the proteinuria primary endpoint, according to a Tuesday Australian bourse filing.

The US Food and Drug Administration (FDA) previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo could support traditional approval of its DMX-200 drug candidate via the 505(b)(1) pathway, should the findings of the study be positive.

Its shares fell 35% in recent trading on Tuesday, reaching a two-year low.

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