Dimerix FY16 Update: Significant Progress on its DMX-200 Program, FDA Confirmation, Trial Recruiting Well

Dimerix has made significant progress on its DMX-200 program for chronic kidney disease.

Dimerix met with the US Food and Drug Administration (FDA) discussing DMX-200 development for Focal Segmental Glomerularsclerosis (FSGS). Dimerix confirmed the DMX-200 regulatory path as an adjunct therapy, not a combination therapy, reducing complexity and costs of trials.

Proteinuria is a risk factor for disease progression in FSGS patients. The FDA confirmed reduction of proteinuria could be devised as a primary end point for registration.

The DMX-200 Phase II trial is recruiting well. Dimerix intends to provide an interim data analysis during Q3 of 2016.

ABOUT DIMERIX

Dimerix is a clinical stage Australian Biotechnology company developing and commercialising novel drug therapies targeted at unmet patient needs, with the lead phase II clinical program (DMX-200) targeting chronic kidney disease (CKD).

The DMX-200 clinical trial is currently recruiting patients with proteinuria, with an interim read out expected in mid 2016. DMX-200 has also received Orphan Designation from the FDA for the treatment of one cause of CKD, Focal Segmental Glomerularsclerosis (FSGS).

The therapeutic rationale for DMX-200 was developed from Dimerix’s core patented technology, Receptor – Heteromer Identification Technology (Receptor – HIT), which can be used to elucidate receptor interactions. Applying this knowledge to drug targets has enabled Dimerix to identify combinations of receptors, which if targeted together, could result in greater efficacy or fewer side effects than traditional approaches.

Dimerix has also assisted several top 10 Pharmaceutical companies with their drug discovery programs by applying the HIT technology. These studies provide validation of Dimerix’s in vitro rationale for pursuing in vivo therapeutic studies.