Dimerix (ASX:DXB) has announced that the first patient has completed the ACTION3 Phase 3 clinical trial, including the initial follow-up period, and has chosen to enter the global open-label extension (OLE) study.
The OLE study is optional for all qualifying patients who have completed the ACTION3 Phase 3 clinical trial and offers a two year treatment with DMX-200.
The OLE study will evaluate the longer-term safety and efficacy of DMX-200 treatment in patients with focal segmental glomerulosclerosis (FSGS) in an open-label setting. It will run with the company’s existing blinded ACTION3 Phase 3 global clinical trial.
All patients in the OLE study will receive DMX-200, regardless of whether they received the drug or placebo during the ACTION3 Phase 3 clinical trial. All patients in the OLE study will continue on the background standard of care blood pressure medication and angiotensin receptor blockers and will be treated for two years with DMX-200. Further information on Open Label Extension studies is outlined later in this announcement.
"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," said Dr David Fuller, Dimerix chief medical officer.
"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. We acknowledge the FSGS patients and their families who continue to inspire us, as well as our investigators, partners and collaborators who provide invaluable assistance in our product development efforts.
"Working together with the renal community, we strive towards bringing this potential new and much-needed therapeutic solution for people living with FSGS,” said Dr Fuller.