Dimerix (ASX:DXB) announced positive safety and efficacy data following a 27-patient Phase 2a proof-of-concept, dose escalation study in chronic kidney disease (CKD) for lead program, DMX-200.
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, was met. In addition, encouraging efficacy signals were demonstrated, with 25% of patients showing a reduction in excess protein in the urine, or proteinuria, of over 50%, beyond that achieved with the highest dosage of current standard-of-care therapy, which is irbesartan.
“The clinically meaningful reductions in proteinuria are highly encouraging and support the rationale behind the program,” CEO, Kathy Harrison, said in a statement.
“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 CKD,” she added. CKD also 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,” Ms. Harrison said.