drugset / Press release

LEAD INVESTIGATOR ENGAGED FOR NEXT STAGE OF DMX-200 TRIALS

2018-05-07 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗

Page 1 of 3 For Immediate Release LEAD INVESTIGATOR ENGAGED FOR NEXT STAGE OF DMX-200 PHASE 2 CLINICAL TRIALS Highlights • Professor Simon Roger, a leading clinical nephrologist has been appointed as Principal Investigator for Dimerix’s DMX-200 Phase 2 clinical efficacy trials in Focal Segmental Glomerulosclerosis (FSGS) and Diabetic Kidney Disease (DKD*) patients • Professor Roger to lead private practice ethics submissions and Professor David Power, the Principal Investigator on the DMX-200 Phase 2a trial, will lead public hospital ethics committee submissions • Dimerix remains on track to release study designs and submit applications for ethics approval for trials during Q2 2018 MELBOURNE, Australia, 7th May 2018: Dimerix Limited (ASX: DXB), a clinical stage biotechnology company is pleased to announce that Professor Simon Roger, Director of Renal Research (private practice) in Gosford, New South Wales, will serve as Principal Investigator for the Company’s coming DMX-200 Phase 2 clinical efficacy trials. Professor David Power, Head of Nephrology at Austin Health in Victoria will lead public hospital involvement, continuing on from his Principal Investigator role in the Company’s Phase 2a trials which concluded successfully last year. In the coming clinical efficacy trials, Dimerix’s lead compound, DMX-200 will be studied in a Phase 2 trial format for the first time in patients with Focal Segmental Glomerulosclerosis (FSGS), an orphan disease which causes nephrotic syndrome+ in children and adolescents, and is a leading cause of kidney failure in adults. Also, following the strong efficacy signals observed in the Company’s Phase 2a trial in patients with diabetic kidney disease (DKD, formerly referred to as diabetic nephropathy), a Phase 2b trial will further explore the efficacy of DMX-200 in this patient population. Through his role of Principal Investigator, Professor Roger is working closely with Dimerix to finalise the protocols for both clinical trials. He will lead the private practice submission for ethics approval, and his private nephrology practice will be a key recruitment point for both trials. Dimerix’s Chief Medical Officer, Associate Professor David Packham said, “ Professor Simon Roger has been the preeminent Australian Investigator on the majority of significant Phase 2 and 3 trials performed in clinical nephrology in the past two decades. We are very happy he has agreed to accept the role of Principal Investigator on both the DMX-200 FSGS and diabetic kidney disease trials.” Dimerix’s CEO, Kathy Harrison commented, “Professor Roger’s deep and highly regarded experience in the development, patient recruitment and management of trials in kidney disease will be of great value to Dimerix as we progress this important program. Having his early involvement in the design of our trial protocols alongside that of our CMO, Associate Professor David Packham, and Professor Power is key to ensuring an optimal trial structure. Page 2 of 3 Along with vendor engagement and finalisation of trial design, Professor Roger’s appointment is one of the final steps before the commencement of our DMX -200 clinical trials in FSGS and diabetic kidney disease. We remain on track to release the study design and submit applications for ethics approval during Q2 2018.” More information on the final trial designs, vendors and trial sites are expected to be released over the coming weeks. Further detail on Professor Roger is outlined in the appendix below. Appendix – Biographical Information, Professor Simon Roger MD FRACP Simon Roger is a Renal Physician who is currently Conjoint Professor, School of Medicine and Public Health at the University of Newcastle; Director of Renal Medicine at the Central Coast Local Health District, Gosford and Director of Renal Research, 37 William St, Gosford. Professor Roger underwent advanced training in Nephrology at Australia’s Westmead Hospital, followed by two years of clinical and laboratory research in London, where he was awarded a Doctorate of Medicine. He returned to Australia’s Gosford Hospital in 1993 as Director of Renal Medicine. In 1993, he was appointed as a nephrologist to Royal North Shore Hospital, and that year, took over as Medical Head of the Division of Medicine at Gosford Hospital. He is a past Chairman of the Gosford Hospital Medical Staff Council. In 2000 he was appointed Clinical Associate Professor at the University of Newcastle and in 2012 he was selected as the inaugural Conjoint Professor of Medicine within his Local Hospital District and the University. His clinical practice includes approximately 120 dialysis patients and supervises over 80 renal transplant patients. Clinical practice is busy, with approximately 20 to 30 new patients and just over 350 patients in follow up per month in private consulting rooms. His research and busy clinical practice has resulted in Professor Roger being requested to contribute to both national and international advisory boards for the management multiple renal disorders and led to his involvement in more than 80 clinical trials. In addition, he has been first or senior author on 63 of 89 publications. *DKD was formerly termed diabetic nephropathy (DN) +Nephrotic syndrome is a clinical disorder characterised by heavy proteinuria and oedema -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: +61 420 249 299 E: [email protected] About Dimerix Bioscience Pty Ltd Page 3 of 3 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 assay, termed Receptor-Heteromer Investigation Technology (Receptor-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 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. 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. Dimerix plans to take DMX-200 for diabetic kidney disease (DKD – formerly termed diabetic nephropathy (DN)) into a Phase 2b trial in H2 calendar 2018 or early calendar 2019. 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 r esidual 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 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, 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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