Dimerix Announces Launch of Dual Phase 2 Trials for CKD

Dimerix Limited, a clinical stage biotechnology company, is pleased to announce designs for its coming clinical trials for lead therapeutic program DMX-200.

Dimerix will undertake two separate trials for patients with two forms of Chronic Kidney Disease (CKD): Focal Segmental Glomerulosclerosis (FSGS) and Diabetic Kidney Disease (DKD*). These have been designed as randomised, double blind placebo-controlled, crossover studies, to maximise potential for data while being highly efficient and cost-effective.

Last year, Dimerix completed a Phase 2a “all comers” clinical trial, where DMX-200 was studied in patients with a group of diseases in the broad category of CKD. In addition to meeting the primary safety end point across the study, a Diabetic Kidney Disease (DKD) subgroup showed a clinically and statistically significant efficacy response that far exceeded other investigational agents in development. Following their completion of dosing, a further outcome saw a number of patients apply to remain on DMX-200 under the Therapeutic Goods Administration’s Special Access Scheme.

The data in patients with DKD patients was sufficiently compelling to support a follow up trial of DMX-200 in this large and commercially attractive patient group.

In parallel, Dimerix will be undertaking the previously planned Phase 2a trial for patients with the disease FSGS, for which the Company has Orphan Drug Designation (ODD) in the USA.


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