Dimerix has achieved another key milestone in its ACTION 3 Focal Segmental Glomerulosclerosis (FSGS) trial with the Data  Safety Monitoring Board  (DSMB) safety review giving it the green light to continue as planned.

Dimerix (ASX:DXB) has confirmed that the independent DSMB has successfully concluded a second review of the ACTION3 phase 3 clinical trial and noted no safety concerns, recommending it continue as planned.

The latest recommendation is entirely consistent with the existing and growing strong safety profile of DXB’s lead drug DMX-200 to treat FSGS.

Undertaking a review by an independent DSMB is consistent with good clinical practice. Its primary responsibilities are to review and evaluate the available study data for participant safety, study conduct and progress, and to make recommendations concerning the continuation, modification, or termination of the trial.

The study protocol for the ACTION3 clinical trial includes oversight by a DSMB as well as provision for interim safety reviews, the second of which has now been successfully completed.

About ACTION 3

DXB’s Phase 3 trial is titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis – or ACTION3 for short. The trial is being conducted at over 70 clinical sites across 11 countries.

ACTION3 is a pivotal multi-centre, randomised, double-blind, placebo-controlled trial of 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 stable, patients aged 18 to 80 years will be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo.

The trial is broadening to 12 to 80 years following the first successful interim analysis.   In January the US confirmed inclusion of paediatric adolescent patients aged 12 to 17 was appropriate in the current global trial, recognising its appropriate safety profile.

The trial has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope), aimed at generating sufficient evidence to support accelerated marketing approval.

A successful outcome in the first interim analysis outcome would see DXB announce a clinically significant and statistically meaningful improvement in proteinuria in patients on DMX-200 vs placebo and that the trial is continuing to Part 2.

Last patient data collection for the phase 3 trial is scheduled for February 26, 2024 with first interim data outcome expected to be reported on, or around March 15, 2024.

Rare disease with no treatment

The rare kidney disease FSGS creates irreversible scarring in the kidney’s filtering units, leading to permanent damage and eventual end-stage kidney failure, necessitating dialysis or transplantation.

Even after kidney transplantation, 60% of patients experience recurrent FSGS. The disease affects both adults and children as young as two years old, but there are currently no approved drugs specifically for FSGS, resulting in limited treatment options and a bleak outlook.

Total FSGS market size across the seven major markets is estimated to be more than US$3 billion by 2032 driven by ~220,000 FSGS sufferers in those areas and premium orphan drug pricing.

DMX-200 has Orphan Drug Designation from the US FDA, EMA, and UK, enabling potential fast track of commercialisation upon successful results.

“The positive recommendations of the DSMB confirm the strong safety profile of DMX-200 previously observed across our multiple clinical studies,” DXB chief medical officer Dr Ash Soman says.

“DMX-200 represents a real hope for the many patients suffering from FSGS kidney disease who currently have limited treatment options.

“We continue to recruit for Part 2 of the study, and we look forward to reporting on the results of the first analysis in March 2024.”

This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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