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DMX-200
(Repagermanium)

Repagermanium is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an angiotensin II receptor blocker (ARB), is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. CCR2 receptor plays important roles in extravasation and transmigration of monocytes under inflammatory conditions. CCR2 and its ligands have been extensively studied in a range of inflammatory diseases in the central nervous system (CNS), including multiple sclerosis, Alzheimer's disease and ischemic stroke.

Wavy Abstract Background

Enroll in this clinical study

David Fuller or Alisha Smith

+61 1300 813 321

ACTION3@dimerix.com

How is Repagermanium studied in FSGS?

ACTION 3 is a pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS. It is desigened to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

Eligibility Criteria

  1. Patients must be 12 to 80 years old

  2. Estimated GFR ≥25 mL/min/1.73 m2 at Screening

  3. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy or documentation of a genetic mutation in a podocyte protein associated with FSGS

  4. Must be either receiving an ARB at the maximal tolerated dose or willing to transition

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