Dimerix (ASX:DXB) has announced positive safety and efficacy data following its now completed 27 patient Phase 2a Proof of Concept, Dose Escalation Study in Chronic Kidney Disease (CKD) for lead program, DMX-200.
The company said Dimerix will now progress with the design for the planned Phase 2b DMX-200 study.
The primary endpoint of the Phase 2a study - demonstrating safety and tolerability - has been met.
Encouraging efficacy signals have been demonstrated, said Dimerix, with 25 per cent of patients showing a reduction in excess protein in the urine (proteinuria) of over 50 per cent, beyond that achieved with the highest dosage of current standard of care therapy (irbesartan.)
According to associate professor David Packham, one of the study's principal investigators and director of the Melbourne Renal Research Group, “These are very encouraging data. DMX-200, and its combination with existing best therapy, appears safe and was well tolerated. An incremental 50% fall in proteinuria is a ‘high bar’ to set in studies of this type and the observation of this efficacy endpoint in 25% of the patients certainly warrants further clinical investigation in a larger, more targeted, population."
“We are delighted that this study has resulted in such positive outcomes. The clinically meaningful reductions in proteinuria are highly encouraging and support the rationale behind the program. Given this is a 'hard to treat' patient group, we now have a very strong indication that the treatment is having a significant impact in slowing the progression of Chronic Kidney Disease," said Dimerix CEO Kathy Harrison.
“CKD is a complex disease and a silent epidemic. Driven by factors like increasing incidence of diabetes, it now affects 1.7 million Australians and 26 million Americans each year” she said. “It is a progressive disease, which means that without treatment, a patient’s proteinuria levels will tend to get worse over time. If we can further demonstrate in our studies that DMX-200 reduces those levels and prevents progression to the need for blood dialysis, we will have a very viable therapy and a huge leap forward in treatment options for patients over the current highest standard of care.”