Dimerix’s (ASX: DXB) phase-two trial for focal segmental glomerulosclerosis (FSGS) has met both primary and secondary endpoints, with 86 per cent of patients showing a response to the drug DMX-200 versus placebo.

This morning’s news drove the share price up as much as 42 per cent to an intra-day high of 54c.

Dimerix (ASX:DXB) share price chart


The primary endpoint was safety; there was no difference in incidence or severity of adverse events between the drug and the placebo.

The secondary endpoints were the proportion of patients who achieved a response during treatment with DMX-200 compared to placebo, as well as the percent change from baseline in 24-hour proteinuria, or proteins leaking into urine, after 16 weeks of treatment.

Of the seven patients enrolled who met the final criteria for inclusion in the final analysis, 86 per cent demonstrated a reduction in proteinuria, with an average 29 per cent change from baseline in 24-hour proteinuria compared to placebo.

Furthermore, 29 per cent (or two of the seven treated patients) achieved a more than 40 per cent reduction in proteinuria.

The company says that unlike other investigational drugs currently in development for FSGS, patients stayed on the standard of care angiotensin receptor blockade.

As a result, the reduction in proteinuria observed from DMX200 is in addition to any reduction in proteinuria expected from background therapy.


A rising star

Dimerix’s star has been rising since late last year when investors began to realise the potential in its two key phase-two drug trials, both of which were completed on time and on budget.

FSGS is a rare kidney disorder for which there is no approved treatment and often leads to end-stage kidney failure. Dimerix has received Orphan Drug Designation for DMX-200 in both the US and Europe for the treatment of FSGS.

The company’s next round of results is the diabetic kidney disease phase 2a study, which is due to report within the next six weeks.

Results from a global study funded by WHO around DMX-200 and acute respiratory symptoms associated with COVID-19 are also due to report later this year. 

“I believe that the results of this phase 2a FSGS study, together with the positive outcomes of the company’s prior phase 2a study in chronic kidney disease, further validates Dimerix’s lead candidate, DMX-200, in sclerotic kidney diseases,” Dr Hiddo Heerspink, chair of the Dimerix Medical Advisory Board, said.

“The positive signals suggest that treatment with DMX-200 may indeed result in clinically meaningful improvements in kidney function when added to the standard of care in patients with FSGS.”

Dimerix chief Nina Webster said the top-line results from the study were positive for the company’s proposed development pathway, which could deliver the first approved pharmacologic treatment for FSGS.