Dimerix (ASX:DXB) said that the ACTION3 phase three trial of its DMX-200 drug candidate in patients with focal segmental glomerulosclerosis completed the recruitment and dosing of 286 adult patients, according to a Monday Australian bourse filing.

The trial is exploring the efficacy and safety of DMX-200 in focal segmental glomerulosclerosis patients when dosed in combination with standard-of-care angiotensin II receptor blocker over two years. It is designed to show evidence of proteinuria reduction and kidney function during the trial, aimed at generating sufficient evidence to support marketing approval.

The trial opened 219 sites for recruitment across 21 countries, including the US, Europe, the UK, Japan, China, Hong Kong, Taiwan, Malaysia, Australia, and New Zealand.

Of the 286 adult patients dosed in the trial, 69 completed the full two-year treatment period, and of those, 65 entered voluntarily into the open-label extension study, representing a 94% uptake.

Dimerix and its US partner, Amicus Therapeutics, plan to seek feedback from the US Food and Drug Administration on the 104-week endpoints and potential submission for accelerated approval.