Dimerix (ASX:DXB) has confirmed that the recruitment of the first 72 patients in its DMX-200 ACTION3 Phase 3 trial in patients with FSGS kidney disease has been achieved.
The company said that once patients have completed the background medication stabilisation period and subsequent re-screening, they are then randomised to receive either DMX-200 or a placebo.
It said the trial would immediately continue to recruit patients for Part 2 of the trial, as well as to allow for any screen failures and patients who drop out or do not comply with the clinical trial protocol.
Part 1 of the trial will conclude after the first interim analysis, once 72 patients have completed 35 weeks of treatment, and is expected to occur in the latter half of 2023.
The ACTION3 Phase 3 trial is recruiting across over 70 sites in 11 different countries.
“The recruitment of the first 72 patients into our key Phase 3 ACTION3 FSGS kidney clinical trial is a significant and exciting milestone for Dimerix,” said Dimerix CEO and managing director, Dr Nina Webster.
“The Dimerix team and the clinical sites have been working extremely hard behind the scenes, with several hundred FSGS patients having been prescreened against the clinical trial inclusion criteria to enrol those 72 patients.
“We are delighted that the time from first patient recruited to the 72nd patient was only 7 months, and we now eagerly await the results of the interim analysis once these patients have been dosed. We also look forward to the strong recruitment momentum achieved to date continuing into Part 2 of the trial.”
The single Phase 3 trial in FSGS patients has two interim analysis points that are designed to capture evidence of proteinuria and kidney function (eGFR slope), aimed at generating sufficient evidence to support accelerated marketing approval.
The company aid that with Part 1 recruited, the trial will continue to recruit and randomise a further 72 patients at all activated clinical sites for Part 2 of the trial effective immediately, to reach a total of 144 patients for the second potential.