Dimerix (ASX:DXB) is set to conduct a blinded review of the ACTION3 phase three study data to confirm statistical assumptions of the primary endpoint during March, according to a Monday Australian bourse filing.
It will use methods specified in the study's statistical analysis plan previously submitted to the US Food and Drug Administration (FDA).
The phase 3 Action3 trial is a placebo-controlled study of the efficacy and safety of its DMX-200 drug candidate in patients with focal segmental glomerulosclerosis who are receiving a stable dose of a blood pressure medication known as an angiotensin II receptor blocker. It is designed to capture evidence of proteinuria reduction and kidney function during the trial, aimed at generating sufficient evidence to support marketing approval.
The FDA previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo is suitable to support traditional approval of DMX-200 via the 505(b)(1) pathway, with estimated glomerular filtration rate as a secondary endpoint.
Its shares were up 1% in recent trading on Monday.