It’s a good end to a big year for Dimerix with recruitment achieved for the first lot of patients to its Phase 3 trial into a rare kidney disease.

Dimerix Limited (ASX: DXB) today confirmed that recruitment of the first 72 patients to its DMX-200 ACTION3 Phase 3 trial in patients with focal segmental glomerulosclerosis kidney disease (FSGS) had been achieved.

The Phase 3 trial is officially titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis (ACTION3 for short).

It is a pivotal multicentre, 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 ACTION3 Phase 3 trial is recruiting across over 70 sites in 11 different countries.

The trial will immediately continue to recruit patients for Part 2 of the trial, as well as to allow for any screen failures and/or patients who drop out or don’t comply with the clinical trial protocol.

Part 1 of the trial is set to 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.

Significant milestone for DMX

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.

DXB CEO and managing director Dr Nina Webster said recruitment of the first 72 patients into its Phase 3 trial is a significant milestone.

“The Dimerix team and the clinical sites have been working extremely hard behind the scenes, with several hundred FSGS patients having been pre-screened 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 seven 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.”

Two key interim analysis points

The single Phase 3 trial in FSGS patients has two interim analysis points built in designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, 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.

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 Accelerated Approval data analysis.

Patients recruited into the trial will need to demonstrate a minimum of six weeks stable dosing of an angiotensin receptor blocker prior to randomisation and dosing with DMX-200 or placebo.

Orphan Drug Designation

DXB has received Orphan Drug Designation for DMX-200 in both the US and Europe, along with the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK, for the treatment of FSGS.

The designations provide regulatory and financial benefits to help bring new drugs to market faster, including reduced fees during the product development phase, protocol assistance from the regulatory authorities, and 7-year (US) and 10-year (Europe) market exclusivity following product approval.

DXB has multiple assets in commercially attractive and growing markets that have a high unmet need, no current marketed competition, and with a potential fast pathway to market.

The biotech is also further progressing diabetic kidney disease and chronic obstructive pulmonary disease (COPD) programs, as well as supporting the investigator-led covid-19 programs.

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.