Clinical Program

Clinical Program 2017-06-04T19:25:56+00:00

Our lead Phase II clinical program targets the significant, under-served therapeutic area of kidney disease.

The primary goal of this program will be to demonstrate the safety of DMX-200 in patients with chronic kidney disease. It is focused on what’s called ‘nephrotic syndrome’, where tiny filters in the kidney break down, allowing proteins to escape from the blood into the urine (proteinuria). Secondary endpoints include reduction of levels of protein in the urine in patients with the disease.

DMX-200 is a combination of two existing drugs, irbesartan and propagermanium that are on the market in various regions around the world. This treatment is based on a mechanistic understanding of receptor-receptor interactions. Read more about DMX-200.

DMX-200 Phase II Clinical Trials

Our research team is led by clinical investigator Professor David Power and is currently enrolling chronic kidney disease patients (with proteinuria) into a Phase II study in Melbourne, Australia.

Up to thirty patients will be enrolled in the dose escalation study to find the optimum therapeutic dose of DMX-200.

Each patient will be stable on a fixed oral dose of irbesartan and then receive escalating doses of propagermanium every four weeks (30mg, 60mg, 90mg, 150mg, 240mg per day) until the primary safety endpoint is confirmed and improvement in proteinuria is observed, as a secondary endpoint.

The research team expects to carry out an initial interim analysis of the Phase II data to confirm the safety of the therapy and observe any changes. It is anticipated that this interim data will be available by mid-2016.

The dose escalation phase will be followed by an 84-day dose expansion phase using the established optimum dose. This phase will be conducted following consultation with the US Food and Drug Administration (FDA) with the intention of ensuring that future US registration is supported.

Clinical Trial Highlights

In April we received TGA Special Access Scheme Approval to supply propagermanium to kidney patients after our DMX-200 Phase II trial; giving patients the opportunity to stay on the treatment.
This indicates that the Investigators involved do not have any safety concerns and consider there is potential benefit for patients to continue on the treatment.

In May we reached our 10 patient milestone and are on track to report interim Phase II Trial Data of DMX-200, confirming we are meeting recruitment targets and timelines.

Expediting/Defining a Regulatory Path to Market

Dimerix intends to meet with the FDA with the view of submitting an IND (investigational new drug) application to commence a pharmacokinetic study in the US.

Discussions with the FDA will focus on the clinical studies required to receive approval for the orphan indication FSGS (focal segmental glomerulosclerosis). FSGS is a sub-group of the larger chronic kidney disease group of conditions.

Dimerix secured orphan designation for the DMX-200 for FSGS from the FDA Office of Orphan Product Development in December 2015.

DMX-200 Composition

DMX-200 consists of the following two drugs:

  1. Irbesartan, an off-patent angiotensin II type I receptor blocker compound used to treat hypertension and nephropathy in Type II diabetic patients.
  2. Propagermanium, a chemokine receptor (CCR2) blocker, which is used for the treatment for Hepatitis B in Japan and available (restricted) as a dietary supplement in the US.

There are no selective CCR2 inhibitors approved for the treatment of chronic kidney disease.

Read more about the science behind DMX-200.

Chronic Kidney Disease – Unmet medical need

Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation of the kidneys. Proteinuria is the most common manifestation of the disease. As the disease progresses it can lead to end-stage renal disease (ESRD) where the kidneys fail. The only treatment for ESRD is a kidney transplant or regular blood-cleansing treatments called dialysis.

Chronic kidney diseases affect at least 10 per cent of the population in Europe and the United States. It is a disease that continues to grow due to the escalating incidence of cardiovascular disease, obesity and diabetes.

Treating kidney fibrosis and other types of chronic kidney disease is a major focus of several pharmaceutical companies. Dimerix is targeting the Orphan Indication of FSGS to expedite its pathway to registration.