Australian biotech Dimerix has announced it will further investigate the therapeutic effects of its DMX-200 on diabetic kidney disease after patients showed a compelling response to the drug during an initial “all comers” phase 2 trial last year.
As well as meeting the primary safety endpoint, patients showed a clinically and statistically significant efficacy response. Following their completion of dosing, a number of patients applied to remain on DMX-200 under the TGA’s Special Access Scheme.
The company said it will now progress DMX-200 into two separate but concurrent Phase 2 clinical studies; one focused specifically on the drug’s therapeutic effects on diabetic kidney disease; and, a planned study on a further specific kidney disease indication - Focal Segmental Glomerulosclerosis.
Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis are subcategories of Chronic Kidney Disease (CKD).
Kidney Health Australia states that around 1-in-10 Australians aged 18 years and over have indicators of CKD, such as reduced kidney function and the presence of the protein albumin in the urine.
According to the organisation, people with CKD have a 2-to-3 times greater risk of cardiac death than those without it.
CKD is also recognised as a huge cost to healthcare systems, as a patient’s condition deteriorates they eventually require blood dialysis, which costs close to $100,000 per year per patient.
DMX-200 tackles CKD by adding a safe anti-inflammatory drug, propagermanium, to the standard of care treatment, irbesartan.
"The two drugs work synergistically to block the signals that cause inflammation, which is a major contributor to the disease’s progression," said the company.
Dimerix’s chief medical officer, Associate Professor David Packham, said the trial design also means that each patient acts as his or her own control and mitigates the impact of variability in disease behaviour from patient to patient.
“We have selected the most robust method of ensuring accurate detection of an efficacy signal for both trials,” said Dr Packham. “The fact that all participants who complete the trial are certain of having received the trial drug for one of two treatment periods will make this much more attractive to patient participation and recruitment.”