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Dimerix's First Patient Completes Phase 3 Trial and Enters DMX-200 Open Label Extension Study for Kidney Disease

• Dimerix has enrolled the first patient into the Open Label Extension (OLE) study for its kidney disease drug candidate DMX-200 after completing the ACTION3 Phase 3 clinical trial. • The OLE study allows patients who have successfully completed the ACTION3 Phase 3 clinical trial to start or continue a two-year treatment of DMX-200 in an unblinded setting. • The OLE study will collect additional long-term data, such as safety and tolerability, to support future potential regulatory filings for DMX-200. • Interim analysis showed DMX-200 outperformed placebo in reducing proteinuria, with the Independent Data Monitoring Committee affirming no safety concerns.

Dimerix Limited (ASX: DXB) has announced that the first patient has successfully completed the ACTION3 Phase 3 clinical trial and has entered the global open-label extension (OLE) study for DMX-200, a drug candidate targeting focal segmental glomerulosclerosis (FSGS). This milestone marks a significant step in advancing DMX-200 as a potential treatment for this rare kidney disease.

Open Label Extension Study Details

The OLE study is an optional extension for patients who have completed the ACTION3 Phase 3 trial, offering a two-year treatment period with DMX-200. This allows all patients who complete the Phase 3 study to receive the drug, regardless of whether they initially received DMX-200 or a placebo during the blinded phase of the ACTION3 trial. All patients in the OLE study will continue on the background standard of care blood pressure medication, angiotensin receptor blocker (ARBs).

Importance of Long-Term Data

For Dimerix, the OLE study is crucial for collecting long-term data on the safety and tolerability of DMX-200. This data is essential for supporting future regulatory filings and potential marketing approval. According to Dimerix's Chief Medical Officer, Dr. David Fuller, the OLE study will provide additional longer-term information regarding treatment with DMX-200, addressing the significant unmet need of patients with FSGS.

Data Collection and Evaluation

Throughout the OLE study, data will be collected periodically. At the end of the treatment period, changes in urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR), both markers of drug efficacy, will be evaluated. A comparison between patients who received placebo and those who received DMX-200 in the ACTION3 Phase 3 trial will also be conducted at the end of the OLE study.

Promising Interim Results

Interim analysis released earlier this year indicated that DMX-200 outperformed the placebo in reducing proteinuria, a key efficacy measure. The trial's Independent Data Monitoring Committee (IDMC) has affirmed no safety concerns related to DMX-200, further bolstering the drug's safety profile. Results of a second interim analysis are expected in mid-2025.

About FSGS

FSGS is a rare kidney disease characterized by irreversible scarring in the kidney's filtering units, leading to permanent damage and eventual end-stage kidney failure, often necessitating dialysis or transplantation.
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Reference News

[1]
First Patient Enters DMX-200 Open Label Extension Study After Successfully Completing ...
biomelbourne.org · Sep 10, 2024

Dimerix Limited announces the first patient completing ACTION3 Phase 3 trial enters global open-label extension (OLE) st...

[2]
Dimerix first patient completes Phase 3 trial and enters into long-term ...
stockhead.com.au · Sep 10, 2024

Dimerix's first patient completed the ACTION3 Phase 3 trial for kidney disease drug DMX-200 and joined the Open Label Ex...

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