DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) Current Status: Phase 3

DMX-200 for FSGS is currently in a Phase 3 clinical trial and has been granted Orphan Drug Designation by the FDA and EMA.

Focal Segmental Glomerulosclerosis (FSGS) is a serious and rare disease that attacks the kidney’s filtering units, the glomeruli.

DMX-200 is a chemokine receptor (CCR2) blocker and is administered to patients taking an angiotensin II type I (AT1) receptor blocker (ARB), which the standard of care treatment for kidney disease. DMX-200 has granted patents in various territories until 2032, with patent applications in that may extend this to 2042 if granted.

Successful Phase 2 Study

In 2020, DMX-200 demonstrated clear benefit to patients with FSGS in its first Phase 2a study in patients specifically with FSGS, following several successful studies in patients with a range of Chronic Kidney Diseases. All trial endpoints were achieved, and DMX-200 was determined to be safe and tolerable.

The common clinical marker for progression of kidney disease is an increase in protein in the urine (known as proteinuria), and a significant reduction in proteinuria demonstrates the progression of kidney failure as been slowed.

In the study:

  • 86% of patients demonstrated reduced proteinuria on DMX-200 versus placebo
  • 29% of patients demonstrated >40% reduction in proteinuria

Noting that this result was in addition to the background therapy of an ARB.

FSGS causes serious scarring to the glomeruli, which leads to permanent kidney damage and kidney failure.

FSGS can have many different causes, and can be classed as either:

  • Primary FSGS: This type of FSGS means that the disease happened spontaneously without a known or obvious cause.
  • Secondary FSGS: This type is caused by another disease or chronic drug use. Examples include: viruses such as HIV or drugs such as anabolic steroids that some people use to speed up their muscle growth

FSGS affects at least 210,000 people globally and is a disease for which there is a recognised medical need for a new or improved treatment.1 The disease progresses rapidly and results in kidney failure, requiring dialysis or kidney transplant. A kidney transplant costs in the region of $260,000 per patient, with ongoing and expensive anti-rejection drugs also costing thousands of dollars per year, and dialysis costs in the region of $100,000 per patient per year and requires regular visits, totaling over 12 hours per week to the medical facility. This is a huge burden on both the patient and the healthcare system.

DMX-200 for FSGS is currently in a Phase 3 clinical trial and has been granted Orphan Drug Designation by the FDA and EMA. Orphan Drug Designation is granted by the FDA and EMA in order to support the development of products for rare diseases. Orphan drug designation qualifies the sponsor of the drug for various development incentives by the FDA and EMA, including: seven years and ten years respectively of market exclusivity if regulatory approval is received, exemption from certain application fees, and an abbreviated regulatory pathway to approval.

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