Dimerix Ltd (ASX:DXB) shares have rallied 18% in morning trade to $0.013, following the company revealing positive results from its Phase 2a Trial of DMX-200 in Chronic Kidney Disease (CKD).
The key fact is that the trial meets the primary safety endpoint and demonstrates encouraging efficacy in a clinically meaningful number of patients.
Highlights
- 25% of patients achieved a greater than 50% reduction in proteinuria, beyond that achieved with the highest dosage of current standard of care therapy; and
- 45% of patients granted ability to continue ongoing treatment under Special Access Scheme upon recommendation of their advising physician, confirming confidence in the treatment.
Kathy Harrison, chief executive officer, commented:
"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.
"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.
"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."
Market for Chronic Kidney Disease
CKD is a growing global health problem affecting over 13% of Australians, and 14% of Americans.
The increase in suffers is due to large number of people living with obesity and diabetes.
The problem is that damaged kidneys “leak” proteins into the urine, known as proteinuria.
This compounds itself which leads to damage of the kidneys.
Where Dimerix comes in is that its Phase 2a Trial of DMX-200 showed a fall in proteinuria.
David Packham, associate professor and one of the Principal Investigators in the study, added:
"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."
Next steps
Preparations are well underway to design the Phase 2b efficacy study for DMX-200.
Using the inputs from this Phase 2a study, Dimerix will now finalise design of the patient inclusion criteria, dosing and timetable, which is expected to start by the end of 2017.