Products: DMX-200 Current Status: Phase 2

Dimerix has used its Receptor-HIT technology to identify a new treatment (DMX-200) that may transform the lives of patients with kidney disease.

DMX-200 is a chemokine receptor (CCR2) blocker and is administered to patients taking irbesartan, an angiotensin II type I (AT1) receptor blocker and the standard of care treatment for kidney disease. DMX-200 has granted patents in various territories until 2032.

Phase 2a Study

In 2017, Dimerix completed its first Phase 2a study in patients with a range of Chronic Kidney Diseases. All trial endpoints were achieved and DMX-200 was determined to be safe and tolerable. In a subsequent sub-group analysis of these results, statistically and clinically significant efficacy signals were seen in patients with diabetes. 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.

Irbesartan, the current standard of care treatment for kidney disease which has been on the market since 2001, has been shown to reduce proteinuria levels by 24% in type 2 diabetics. DMX-200, when administered to patients already taking irbesartan, reduced proteinuria levels by a further 36%. To be clear, this 36% is in addition to the 24% already seen from irbesartan and may result in delaying kidney failure and dialysis, compared to taking irbesartan alone. The compelling results from this study prompted the decision to raise capital in early 2018 towards funding two different clinical trials in 2018: one for patients with Diabetic Kidney Disease; and the second for patients with another form of inflammatory kidney disease, Focal Segmental Glomerulosclerosis (or FSGS).

Dimerix DMX-200 advantages:

1.

New use of known drugs

Both irbesartan and DMX-200 have well known safety profiles, as they have each been used safely for many years. This minimizes the safety risk of DMX-200 to patients.
2.

Doesn’t take patients off standard of care

DMX-200 does not require patients to stop taking irbesartan, which stabilizes their blood pressure and decreases proteinuria. Taking patients off standard of care risks potentially detrimental consequences relating to uncontrolled blood pressure. Therefore, patients get to stay on their well-known and safe blood pressure controlling drug and get the additional proteinuria reduction of DMX-200.
3.

Attacks inflammation

Current standard of care drugs, such as irbesartan, reduce the leakage of protein into the urine. However, the reduction of kidney function continues unless the damage caused by inflammation is controlled, leaving many treatment options ineffective. By adding the anti-inflammatory drug DMX-200 to irbesartan, DMX-200 aims to combat this inflammation, preserving kidney function.
4.

Supported by Receptor-HIT platform

DMX-200 was identified using the Dimerix Receptor-HIT platform. In a meeting with the United States' FDA, the relevance of heteromers to drug development was confirmed, which is the basis of Dimerix’s Receptor-HIT platform and DMX-200.
5.

Orphan Drug Designation for Focal Segmental Glomerulosclerosis (FSGS)

Dimerix has secured orphan drug designation for DMX-200 in FSGS in the US and Europe. Current treatment options for FSGS are limited and have significant side effects, meaning there is a desperate need for safe treatments. Through the orphan drug program, DMX-200 will be have access to a number of regulatory and financial incentives, potentially meaning shorter trials and lower costs compared to other therapies.

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