Dimerix has announced another milestone for its pivotal Phase-3 trial with a positive report on a key review evaluating available study data for participant safety, study conduct and progress.

ASX listed biotech Dimerix (ASX:DXB) today confirmed that an independent Data Safety Monitoring Board (DSMB) has successfully concluded a review of its ACTION3 Phase-3 clinical trial into Focal Segmental Glomerulosclerosis (FSGS).

Following the routine, scheduled review, the DSMB has noted no safety concerns and recommended that the clinical trial continue as planned.

DXB said the findings are consistent with the existing and growing strong safety profile of its lead drug DMX-200.

Undertaking a review by an independent DSMB is consistent with good clinical practice and was pre-specified in the analysis plan.

The primary responsibilities of the DSMB 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 reviews, the first of which has now been successfully completed.

Global trial now has 96 patients

The first 72 patients were recruited to the pivotal Phase-3 trial at the end of last year.

The trial is actively recruiting across clinical sites globally, with 96 patients having now been recruited as of February 7, 2023.

The trial is titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis – or ACTION3 for short.

It is a 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 type receptor blocker (ARB) – the standard of care treatment for hypertension and kidney disease.

Once the ARB dose is stable patients, aged 18 to 80 are be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo. The trial was broadened to adolescents aged 12 to 17 following the first successful interim analysis.

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

Part 1 interim analysis of the trial data will conclude once 72 patients have completed 35 weeks treatment.

Large addressable market

FSGS is a rare disease with no existing registered treatment options specifically for sufferers.

The total global FSGS market was valued at US$12.6 billion in 20222 with a CAGR of 8.2%, driven by ~220,000 FSGS sufferers across the seven major markets and premium orphan drug pricing.

DMX-200 has previously received Orphan Drug Designation with the FDA, EMA, and UK, allowing potential fast track of commercialisation if successful.

It is also protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042.

Goal to complete pivotal trial ASAP

DMX Chief Medical Officer Dr Ash Soman said the DSMB’s positive recommendation is a key milestone, which enables the company to continue patient enrolment as planned and to complete the trial as soon as possible.

“The outcome from this DSMB analysis is entirely consistent with the strong existing and growing safety profile of DMX-200. We have seen solid recruitment momentum across the study, and we look forward to reporting on the results of the interim analysis once the first 72 patients reach 35 weeks treatment,” Dr Soman said.

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.