- 01First patient completes 2-year DMX-200 extension.
- 0293% of ACTION3 completers joined extension.
- 03Phase 3 adult cohort: 333 patients across 21 countries.
Clinical-stage biopharmaceutical company Dimerix (ASX: DXB) has achieved a significant milestone with the first patient completing two years in its open label extension (OLE) study of DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS).
The milestone marks four years of continuous participation in the clinical development program, highlighting sustained patient engagement and providing important long-term safety and efficacy data for DMX-200 in patients with FSGS.
The OLE study allows patients who complete Dimerix’s pivotal ACTION3 Phase 3 clinical trial to receive DMX-200 for up to two years in an unblinded setting, regardless of whether they received DMX-200 or placebo during the randomised blind phase.
Currently over 90% of eligible patients who have completed ACTION3 have elected to continue onto the OLE study, representing a continuation rate of 93%, with patients who complete the OLE study offered continued access to DMX-200 through the post-trial-access (PTA) scheme once ethics approval has been achieved.
Testing Efficacy and Safety
The Phase 3 study is a multi-centre, randomised, double-blind, placebo-controlled study to test the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Once the ARB dose is stabilised, patients are randomised to receive either DMX-200 (120 milligram capsule twice daily) or a placebo.
The ACTION3 adult cohort is fully recruited with 333 patients randomised and dosed across 219 sites in 21 countries including the US, Europe, Japan, China, Australia and New Zealand.
The final adult patient commenced treatment in March, transitioning the study from recruitment into treatment and follow-up, and they are expected to complete dosing within 12 months.
Recruitment of paediatric patients aged 12-17 years continues as an independent cohort within the ACTION3 program and may support future expansion into adolescent indications in key territories.
High Patient Commitment
Dimerix chief executive officer Dr Nina Webster said the high level of participation in the OLE study reflected the commitment of patients, investigators and study sites to the ACTION3 program and DMX-200.
“The completion of four years of study participation by the first patient in our DMX-200 clinical program represents an important milestone for Dimerix and the broader FSGS community,” she said.
“Long-term participation of this nature […] provides us with an opportunity to gather valuable longer-term information on DMX-200.”
“We are particularly encouraged that over 90% of eligible patients completing the ACTION3 study have elected to continue into the open label extension study, and are excited to potentially offer patients who complete the OLE study with the option to continue treatment through a PTA program.”
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