Dimerix first patient completes Phase 3 trial and enters into long-term DMX-200 Open Label Extension study

First patient completes Phase 3 trial and joins Open Label Extension study for its kidney disease drug candidate DMX-200
All patients from its ACTION3 Phase 3 clinical trial are eligible to receive the drug under the OLE
Results from study will provide additional long-term data to support future potential regulatory filings

Special Report: Dimerix has enrolled the first patient into the Open Label Extension 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 optionally start or continue a two-year treatment of DMX-200 in an open label (unblinded) setting.

This allows all patients who complete the Phase 3 study to receive the drug regardless of whether they received it or a placebo during the randomised and blinded phase of the ACTION3 Phase 3 clinical trial.

Importantly for Dimerix (ASX:DXB), the OLE study allows for the collection of additional long-term data such as safety and tolerability to support future potential regulatory filings.

“The initiation of the open label extension study is another important milestone as we advance DMX-200 as a potential treatment to address the significant unmet need of patients with FSGS (focal segmental glomerulosclerosis),” chief medical officer Dr David Fuller said.

“The Open Label Extension study will provide us with additional longer term information regarding treatment with DMX-200, and we are pleased to be able to provide the active drug to all patients who complete the ACTION3 Phase 3 trial, irrespective of treatment arm.

“We are delighted that the investigators, participants and regulatory authorities endorse us moving forward into this important longer-term study, supported by the strong safety profile to date of the drug.”

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.

DMX-200

Interim analysis released in March found that DMX-200 outperformed the placebo in reducing proteinuria (efficacy), as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients.

This suggests the potential for a statistically significant and clinically meaningful reduction in proteinuria at the study’s conclusion.

To top it off, the trial’s Independent Data Monitoring Committee (IDMC) affirmed no safety concerns related to DMX-200, further enhancing the drug’s safety profile.

Results of a second interim analysis are expected in mid-2025.

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.