- Dimerix (DXB) receives approval from the US FDA to proceed with a phase three study of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS)
- An Investigational New Drug (IND) application for the study, dubbed ACTION3, is now active, paving the way for patient recruitment across 75 sites in 12 different countries
- The third-phase trial has two interim analysis points designed to capture evidence of proteinuria and kidney function during the study
- Dimerix says it expects the first part of the study to be completed during the first half of 2023, once 72 patients have completed 35 weeks of treatment
- DXB shares are trading grey at 13 cents each as of 1:28 pm AEST
Dimerix (DXB) has received approval from the US Food and Drug Administration (FDA) to proceed with a phase three study of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS).
An Investigational New Drug (IND) application for the clinical study, dubbed ACTION3, is now active, paving the way for patient recruitment across 75 sites in 12 different countries, with 19 of those clinical sites having been selected in the US.
“FDA approval of our IND for the Phase Three FSGS study is an important milestone, as it includes regulatory review of all manufacturing, nonclinical and clinical data that we have generated for the DMX-200 program to date,” Dimerix CEO and Managing Director Dr Nina Webster said.
The aim of the study is to generate sufficient evidence to support accelerated marketing approval for Dimerix’s product.
The single third-phase study in FSGS patients has two interim analysis points designed to capture evidence of proteinuria and kidney function (eGFR slope) during the study.
The first part of the study will conclude after the first interim analysis — once 72 patients have completed 35 weeks of treatment — and is expected to occur in the first half of 2023.
Under the second part of the study, patients will need to demonstrate a minimum of six weeks of stable dosing of an angiotensin receptor blocker prior to randomisation and dosing with DMX-200 or placebo.
DXB shares were trading grey at 13 cents each as of 1:28 pm AEST.