Dimerix to progress DMX-200 to phase 3 trial to treat kidney disease FSGS

Melbourne biotech released an additional analysis of FSGS and diabetic kidney disease studies that concluded last month
Studies showed treatment with DMX-200 resulted in a decline in proteinuria in patients across both Phase 2 clinical studies
Study showed drug candidate reduced an inflammatory biomarker known as MCP-1
The CCR2 antagonist may have caused a “legacy effect” – permanently changing the course of both FSGS and diabetic kidney disease

Dimerix (ASX:DXB) says its medical advisory board is unanimously recommending the company progress its drug candidate DMX-200 to a phase 3 trial to treat a rare kidney disease known as FSGS.

It announced the decision after further analysing its FSGS and diabetic kidney disease trials, which found that not only did patients who received the Melbourne biotech’s drug candidate show a decline in proteinuria, but also showed a 39 per cent reduction in an inflammatory biomarker called MCP-1, compared to when they were just receiving placebo.

Intriguingly, the company also can’t rule out that its drug candidate DMX-200 caused what’s known as a “legacy effect” – permanently changing the course of the disease – in both studies.

Dimerix shares dropped in September after the phase 2 clinical trial using the chemokine receptor (CCR2) antagonist to treat 40 patients with diabetic kidney disease failed to meet clinical endpoints with statistical significance. But Dimerix has said that despite the market’s reaction, the trial results were misinterpreted .

In releasing a further analysis of the study on Tuesday, it said that the failure to meet clinical endpoints with statistical significance could have been because of the study’s crossover design.

The patients were treated with both DMX-200 and placebo, with a six-week “washout period” between treatments.

The group that received DMX-200 first didn’t return to baseline during that period, resulting in a significantly lower starting baseline of proteinuria, a key protein level used to measure the progression of kidney disease.

“A potential disease-modifying effect has not been ruled out, where the patient may have continued DMX-200 benefit through the washout period, after they had stopped taking DMX-200,” Dimerix said.

“This can be an indicator that the drug may have a lasting positive effect on the function of the kidney.”

“The data suggests that it could be a disease-modifying effect,” Dimerix chief executive Nina Webster told Stockhead, using another term for “legacy effect”.

“And we are quite excited by that.”

There’s a lot at stake, given that diabetic kidney disease affects an estimated 29 million Americans and 1.9 million Australians, with its incidence growing. There hasn’t been a new drug approved to treat it since 2001.

Data supports hypothesis

The company said that the “high correlation” between DMX-200 treatment and the reduction in MCP-1 levels supports Dimerix’s theory that DMX-200 is effective in diseases where active inflammatory processes are driving disease progression.

The company’s medical advisory board is further analysing the remaining data and planning for what steps to take next in relation to diabetic kidney disease, Dimerix said.

The medical advisory board recommended Dimerix move forward on a phase 3 study of using DMX-200 to treat focal segmental glomerulosclerosis (FSGS), a serious and rare disease that attacks the kidney’s filtering units.

Dimerix shares closed Tuesday up 1.9 per cent to 28c.

Biotech roundup

Elsewhere in the biotech sector on Tuesday:

Rhythm Biosciences (ASX:RHY) reported that Northern Beaches Clinical Research had joined its clinical trial to develop a low-cost, simple blood test to detect colorectal cancer. The clinical research centre is the seventh site to join the study, with the company looking to add still more sites.

Opthea (ASX:OPT) reported it had been given an $8.5 million research and development tax credit from the Australian Taxation Office. The company said it would strengthen its balance sheet as it prepared to recruit patients into phase 3 clinical trials of its lead drug candidate to treat wet age-related macular degeneration.

Zelira Therapeutics (ASX:ZLD) announced that its proprietary US-made medicinal cannabis formulations were now available by prescription in Australia to treat autism spectrum disorder. The products have been sold in Pennsylvania and licensed in Louisiana.

Telix Pharmaceuticals (ASX:TLX) has completed phase 1 enrolment of its study of its renal cancer diagnostic imaging product in Japan. The study will enrol about 40 patients in total. Another phase 3 study is recruiting patients globally.

At lunchtime, Zelira shares were up five per cent, Telix shares were down 2.4 per cent, Opthea shares were down 3.4 per cent and Rhythm shares were flat.