drugset / Press release

DMX-200 Phase 2a Data Presentation

2017-08-16 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗

Page 1 of 2 For Immediate Release ASX/Media Release Dimerix to present analysis of DMX-200 Phase 2a Clinical Trial in Chronic Kidney Disease at the American Society of Nephrology (ASN) annual Kidney Week 2017 MELBOURNE, Australia, 16th August 2017: Dimerix Limite d (ASX: DXB), is pleased to announce that a detailed analysis of the data from the DMX-200 Phase 2a clinical trial in Chronic Kidney Disease will be announced to the ASX coincident with its feature as a poster presentation at the American Society of Nephro logy (ASN) Kidney Week 2017, to be he ld in New Orleans, Louisiana from October 31 to November 5, 2017. Associate Professor David Packham, a principal investigator on the DMX -200 clinical trial said, “We are very pleased to be able to present data from the DMX-200 clinical trial at the AS N Kidney Week Meeting . This meeting is known as the world’s pre-eminent gathering of clinical and scientific professionals who are working on developing kidney disease treatments.” Kathy Harrison, Dimerix CEO said: “ The ASN’s annual Kidney Week is typically attended by more than 13,000 international kidney specialists and Dimerix has been allocated a poster presentation slot in the clinical trials section of the first session of the conference. It is an exciting opportunity for us to expand upon recently announced top line results of our DMX-200 Phase 2a clinical trial in Chronic Kidney Disease within this world leading forum.” About the poster presentation Those attending the ASN’s annual Kidney Week can view Dimerix’s poster using the details below. Session Title: 305-PO01 CKD: Clinical Trials and Tubulointerstitial Disorders Session Date, Time: November 2, 2017 from 10:00 AM to 12:00 PM Your Poster Board #: TH-PO501 Poster Title: A Phase 2a trial of DMX-200: synergistic blockade of AT1R and CCR2 in patients with Chronic Kidney Disease (CKD) -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] About Dimerix Bioscience Pty Ltd Dimerix Limited’s (ASX: DXB) wholly owned subsidiary Dimerix Bioscie nce Pty Ltd is a clinical -stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary assay, termed Receptor -Heteromer Investigation Technology (Rec eptor-HIT). Page 2 of 2 This assay enables the identifi cation 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 providing 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 (9), IgA nephropathy (6), and other proteinuric diseases (12). 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 CKD residual proteinuria continues even with optimal use of existing therapies. Accordingly, therapies de signed to further reduce, or abolish, proteinuria, are eagerly sought. The rationale behind the DMX -200 program is to provide patients with a therapy that 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, Johns tone 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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