Dimerix announces initiation of DMX-200 OLE study

Dimerix Limited (ASX:DXB) has announced the initiation of the DMX-200 Open Label Extension (OLE) study, with the first patient entering after successfully completing the ACTION3 Phase 3 clinical trial. The OLE study offers a 2-year treatment with DMX-200 to patients who have completed the Phase 3 trial, providing an opportunity to evaluate the longer-term safety and efficacy of the treatment in an open label setting.

Executive commentary on DMX-200 OLE study initiation

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. 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.

Summary of DMX-200 OLE study initiation

Dimerix Limited (ASX:DXB) has initiated the DMX-200 Open Label Extension (OLE) study, allowing patients who completed the ACTION3 Phase 3 clinical trial to opt for a 2-year treatment with DMX-200 in an open label setting. The OLE study aims to collect additional long-term data on DMX-200 to support potential future regulatory filings. The company's Chief Medical Officer, Dr David Fuller, expressed enthusiasm for the initiation of the OLE study and highlighted the support from investigators, participants, and regulatory authorities. The study will focus on evaluating the longer-term safety and efficacy of DMX-200, providing valuable insights for addressing the unmet medical needs of patients with FSGS.