Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-145

Dimerix (ASX: DXB) receives positive results in DMX 200 clinical study

Health Care

ASX: DXB MCAP $146.3M

Jessica De Freitas Markets Reporter [email protected] 14 September 2020 10:30


Managing Director & CEO, Dr Nina Webster
Source: Dimerix

• Dimerix (DXB) has announced positive results from a phase two clinical trial evaluating the safety and efficacy of DMX-200 in patients with diabetic kidney disease
• The study administered 240 milligrams of DMX-200 to the patients who were already taking a 300-milligram dose of irbesartan which is the current the standard of care
• The study showed that patients receiving DMX-200 compared to those receiving a placebo, experienced a higher reduction in albuminuria which is a sign of kidney disease
• Dimerix will investigate the results further to support future its DMX 200 kidney disease studies.
• It will also continue planning a phase three trial in FSGS, a rare kidney disorder that doesn't currently have an approved pharmacologic treatment

Dimerix (DXB) has announced positive results from a phase two clinical trial testing its DMX-200 drug candidate on patients with diabetic kidney disease.

The study was a double-blind, randomised, placebo-controlled study aimed at evaluating the safety and efficacy of DMX-200 in patients with diabetic kidney disease who are receiving a stable dose of irbesartan which is the current the standard of care.

The study administered 240 milligrams of DMX-200 to the patients who were already taking a 300-milligram dose of the angiotensin receptor blocker, irbesartan.

"Whilst the study did not show a statistically significant difference in its primary endpoint, the effects in people with baseline albuminuria of over 500mg/g provides informative insight that certainly warrants further analysis," Dimerix Medical Advisory Board Chair Dr Hiddo Heerspink said.

The trial resulted in a significant difference in albuminuria reduction in patients receiving DMX-200 compared to those receiving a placebo with a higher starting baseline albuminuria.

Albuminuria is a sign of kidney disease and means that you have too much albumin in your urine. A healthy kidney doesn't let albumin pass from the blood into the urine.

Dimerix observed an 18 per cent reduction in albuminuria in patients with an albuminuria value of more than 500mg/g in addition to standard of care compared to those receiving a placebo.

Furthermore, 64 per cent of patients with the higher starting albuminuria level demonstrated a reduction in albuminuria versus a placebo with 56 per cent achieving a greater than 25 per cent reduction in albuminuria versus placebo.

Importantly, 25 per cent of patients demonstrated a more than 30 per cent reduction in albuminuria on treatment with DMX-200 versus placebo.

"The confirmation of a clinically significant fall in albuminuria in patients with type two diabetes and high levels of residual albuminuria indicating poor prognosis undoubtedly warrants further investigation, focusing on this most at-risk group with high levels of residual albuminuria despite best therapy," Associate Professor David Packham said.

Dimerix will now investigate the relationship between treatment effect in this study and other patient factors, such as inflammatory biomarkers, concomitant medications or legacy effect.

The company will then use these findings to support future DMX 200 kidney disease studies.

Dimerix will also continue planning its proposed phase three trial in FSGS, a rare kidney disorder that doesn't currently have an approved pharmacologic treatment.