Further US patent allowed for DMX-200

Page 1 of 2 For Immediate Release FURTHER US PATENT APPLICATION ALLOWED FOR DMX-200 MELBOURNE, Australia, 2 July 2018: Dimerix Limited (ASX: DXB), a clinical stage biotechnology company, is pleased to announce the receipt of a Notice of Allowance from the US Patent and Trade Mark Office (USPTO) of a further US patent application for its lead therapeutic program DMX-200. The newly allowed patent application, number 15/086,823, entitled COMBINATION THERAPY claims a pharmaceutical composition comprising a broad range of angiotensin receptor blockers and chemokine 2 receptor (CCR2) antagonists. This application is part of the same family as the method of use patent issued in 2016, with a priority date of 11 Jan 2011. The allowed claims relate to the class of compounds used in Dimerix’s DMX-200 program, under which an initial Phase 2a trial in Chronic Kidney Disease was successfully reported in 2017 and which will be studied again shortly via the Company’s ACTION trials ; simultaneous Phase 2 clinical studies in the areas of Focal Segmental Glomerulosclerosis (FSGS) and Diabetic Kidney Disease (DKD). Under the ACTION study format (originally announced 15 May 2018) , every patient on each of the two Phase 2 trials will receive the best standard of care medication (Irbesartan – an angiotensin receptor blocker ) and receive the trial drug propagermanium (a CCR2 antagonist). Dimerix’s CEO, Kathy Harrison commented, “The allowance of this additional patent in the USA further substantiates Dimerix’s broad claims over the use of a CCR2 antagonist with the standard of care angiotensin receptor blocker for treatment of (kidney) disease. It is further validation of the strength of the Dimerix intellectual property portfolio in a therapeutic approach with growing activity levels.” Upon issuance, a patent number will be allocated and the patent will provide protection until 2032. An extension of the patent term may also be available in the USA (and other regions), to compensate for the time taken to develop a pharmaceutical, once a pharmaceutical product protected by the patent is registered in the USA. -END- For further information, please visit our website at www.dimerix.com or contact the individuals outlined below. At the Company Investor Relations Kathy Harrison Dimerix Limited Chief Executive Officer Tel: +61 419 359 149 E: [email protected] Glen Zurcher IR Department Account Director Tel: +61 411 117 774 E: [email protected] 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 de veloping new therapeutic models identified Page 2 of 2 using its proprietary assay, 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. 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 propagermaniu m to a stable dose of i rbesartan. 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, DM X-200 was shown to reduce levels of proteinuria in a number of patients. This was deemed a “clinically meaningful ” result by leading clinicians . Sub set analysis released in November 2017 showed both a statistically significant and clinically meaningful reduction in proteinuria in the diabetic nephropathy cohort of patients Dimerix intends to take DMX -200 into clinical trials to test efficacy in calendar 2018 starting with its lead program in focal segmental glomerulosclerosis (FSGS), for which it has orphan drug designation in the US as well as for diabetic kidney disease (DKD). (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.

The release as fetched from its publisher. dimerix.com ↗