DMX-200 Dosage Optimisation Study Successfully Completed

Page 1 of 2 For Immediate Release ASX/Media Release DMX-200 Dosage Optimisation Study Successfully Completed in Preparation for Phase 2b trial MELBOURNE, Australia, 8 January 2018: Dimerix Limited (ASX: DXB), a clinical stage biotechnology company today announces top -line results from a recent pharmacokinetic (PK) study of an extended release tablet formulation for their DMX -200 program targeting Chronic Kidney Disease (CKD). The study found a newly formulated extended release tablet of DMX-200 taken twice daily (against three times daily for the previous formulation) increases the duration of release of DMX- 200 in the human body. The extended release formulation provides a clear benefit by extending the half-life of propagermanium in patients, and will allow a reduced number of daily doses in further studies. Kathy Harrison, Dimerix CEO stated “Taking two instead of three tablets daily will support compliance rates from patients both in our upcoming Phase 2b trial and also for the marketed product. Compliance w ith recommended dosing is a vital component of trial success , but also commercial success and physician confidence in the product . The extended release formulation also offers further intellectual property protection for our DMX-200 program”. The new tablet formulation was manufactured in a Good Manufacturing Practice (GMP) in -line with FDA guidelines, enabling the tablet to be reproduced and used for future studies including the upcoming Phase 2b trial. On the back of these results Dimerix is in the process of patenting the extended release formulation, strengthening the groups patent portfolio around the DMX -200 program which already includes the use of CCR2 antagonists in conjunction with, or sequential to, administration of angiotensin receptor bl ockers (ARB’s) , inclusive of treatment in CKD. These patents are granted in the USA, Australian and Japan, with applications pending in a number of major pharmaceutical markets. -END- For more information please contact: At the company Media (Australia) Media (International) Kathy Harrison Chief Executive Officer Dimerix Limited Tel: +61 419 359 149 E: [email protected] Andrew Geddes Tel: +61 408 677 734 E: [email protected] Sue Charles/Daniel Gooch Tel: +44 (0)20 7866 7905 E: [email protected] At the company Media (Australia) Media (International) Kathy Harrison Chief Executive Officer Dimerix Limited Tel: +61 419 359 149 E: [email protected] Andrew Geddes Tel: +61 408 677 734 E: [email protected] Sue Charles/Daniel Gooch Tel: +44 (0)20 7866 7905 E: [email protected] Page 2 of 2 About Dimerix Bioscience Pty Ltd Dimerix Limited’s (ASX: DXB) wholly owned subsidiary Dimerix Bioscience Pty Ltd is a clinical -stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary as say, termed Receptor -Heteromer Investigation Technology (Rec eptor-HIT). This assay enables the identification of pairs of receptors that function in a joint manner (interact) when ligands, small molecule drugs, peptides or antibodies, bind to them. The Receptor-HIT technology was used to identify DMX -200 in an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. In addition to its own therapeutic programs, the company also earns revenue by p roviding this technology to global pharmaceutical companies. For more information see www.dimerix.com About the DMX-200 program DMX-200 which successfully completed a Phase 2a clinical trial in humans, is being developed as an adjunct therapy, adding propagermanuim to a stable dose of irbesartan. Irbesartan is an off -patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients. Propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti - inflammatory properties. DMX-200 has been shown to improve the outcome of chronic kidney disease by reducing proteinuria by more than 50 per cent in animal models (1). Dimerix released the results of its Phase 2a clinical trial in humans for DMX-200 in July 2017. The trial met its primary endpoint of safety and tolerability in the participating patient group , which included patients with diabetic nephropathy (10), IgA nephropathy (6), and other proteinuric diseases (11). As a secondary endpoint, DMX-200 was shown to reduce levels of proteinuria in a number of patients. This was deemed a “clinically meaningful” result by leading clinicians. Preparations for a Phase 2b trial are underway which will test for efficacy and is expected to start by the end of calendar 2017. About Chronic Kidney Disease Chronic Kidney Disease (CKD) is a disorder in which patients show progressive loss of renal function usually accompanied by excess protein in the urine (proteinuria). Levels of proteinuria predict rate of decline of renal function (higher levels = more rapid decline). In part this is believed to reflect direct toxicity, or damage, to the kidneys by proteinuria itself. This establishes a cycle of worsening renal function leading in turn to increasing proteinuria and further kidney damage. Many CKD patients progress to a need for renal replacement therapy or dialysis and / or experience excessive morbidity and mortality from cardiovascular-related diseases. The prevalence of CKD is rising and as such there is urgent need for treatments that can benefit CKD patients, including reducing proteinuria. In most cases of C KD residual proteinuria continues even with optimal use of existing therapies. Accordingly, therapies designed to further reduce, or abolish, proteinuria, are eagerly sought. The rationale behind the DMX -200 program is to provide patients with a therapy t hat can reduce proteinuria in addition to that achieved with standard best therapy. The unmet need of CKD patients is reinforced by Dimerix’s Orphan Drug Designation. (1) Functional interaction between angiotensin II receptor type 1 and chemokine (C-C motif) receptor 2 with implications for chronic kidney disease. Ayoub MA, Zhang Y, Kelly RS, See HB, Johnstone EK, McCall EA, Williams JH, Kelly DJ, Pfleger KD. PLoS One. 2015 Mar 25;10(3):e0119803. doi: 10.1371/journal.pone.0119803.

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