SDIMERIX ANNOUNCES POSITIVE ADDITIONAL DATA TO SUPPORT DMX-200 DEVELOPMENT IN KIDNEY DISEASE • DMX-200 demonstrated a reduction in proteinuria across both Phase 2 studies and a clear benefit to patients with both FSGS and diabetic kidney disease • DMX-200 reduced inflammatory biomarker by 39% versus placebo: translates to reduced inflammation and subsequent fibrosis • Inflammatory biomarker data supports previously announced positive data for both studies • Following detailed review of the FSGS data, the Medical Advisory Board unanimously agrees with progression of DMX-200 to a pivotal study in FSGS patients • DMX-200 safe and well-tolerated across all studies to date; benefits outweigh any potential risk to patients • Preparation of pivotal FSGS clinical study underway with pathway to accelerated approval MELBOURNE, Australia, 27 October 2020: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company, is pleased to announce new positive data from both the Phase 2a clinical study in Focal Segmental Glomerulosclerosis (FSGS) patients and the Phase 2 clinical study in diabetic kidney disease patients that supports the continued development of DMX-200 in kidney diseases. The additional data can be seen in the updated Investor Presentation attached, and is also available on the Dimerix website, www.dimerix.com. DMX-200 treatment resulted in a decline in proteinuria in FSGS patients and in diabetic kidney disease patients in all treatment groups across both Phase 2 clinical studies (slides 9, 12, 17 and 19 in the attached presentation). Additionally, for diabetic kidney disease patients with a marginally higher starting baseline, treatment with DMX-200 versus placebo showed statistically significant reduction in proteinuria versus placebo. The Medical Advisory Board unanimously agrees that the encouraging data supports the ongoing development of DMX-200, and that it should be confirmed by a larger pivotal randomised controlled trial for patients with FSGS as was discussed between Dimerix and the FDA in November 2019. A high correlation was observed between the severity of patient proteinuria and the molecular target of DMX-200 – an inflammatory molecule called Monocyte Chemoattractant Protein-1 (MCP-1) – across both studies (slides 11 and 18 in the attached presentation). In addition to the reduction in proteinuria, DMX-200 reduced the inflammatory biomarker MCP-1 by 39% versus placebo in the FSGS study and this translates to reduced inflammation and subsequent fibrosis (scarring) in the kidney. The data further supports the proposed mechanism of action of DMX-200 being effective in diseases where active inflammatory processes are driving disease progression.
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