Dimerix is pleased to announce the appointment of a Medical Advisory Board (MAB) to help guide the Company’s DMX-200 clinical program.
MELBOURNE, Australia - 18th October 2017 - Dimerix (ASX: DXB) is pleased to announce the appointment of a Medical Advisory Board (MAB) to help guide the Company’s DMX-200 clinical program.
The Medical Advisory Board will provide clinical and strategic input into the Company’s lead program, DMX-200 in Chronic Kidney Disease and will provide guidance to the Company as it shapes and progresses its DMX-200 programs. The MAB will have no formal governance role.
Associate Professor David Packham (MD, MB, BS (Hons), FRCP, FRACP) will lead the MAB in the position of Chair, where he will be joined by:
- Professor David Power, MD, MB, BS, PhD, MRCP(UK), FRACP
- Daniel Cattran, MD, FRCP (C)
- Alessia Fornoni, MD, PhD, FASN
- Jonathan Hogan, MD
Further background on each of the Advisory Board members can be found in the appendix following.
Kathy Harrison, group CEO commented, “We are delighted to have attracted such a respected group of nephrologists to join this inaugural Medical Advisory Board, particularly as the DMX-200 program in Chronic Kidney Disease moves closer to phase 2b trials.
“The formation of this Board will help drive forward the clear clinical potential of our DMX-200 program. The MAB members’ insights and guidance will prove invaluable as we design and advance our program.”
The Medical Advisory Board is compensated for its time through a combination cash and equity based remuneration, with the total number of shares to be issued of 2,743,000 (pre consolidation) and a package of options to be issued to the approximate value of $10,000 the precise number and exercise price to be determined.
Appendix – Medical Advisory Board Summary
Associate Professor David Packham (Chair)
Assoc Prof Packham is the Director of the Melbourne Renal Research Group, a specialist clinical research facility for nephrology studies. In this capacity, he has been involved in the development of protocols for numerous clinical trials and has held the position of national or regional co-ordinator for many trials. He has authored and co-authored over 80 peer review publications. His research group has participated in over 40 international clinical trials in a variety of chronic kidney conditions, and is a member of the clinical trial network for the NephCure Accelerating Cures Institute. A/Prof Packham was a member of the Consultative Council for Clinical Trial Research; advising the Minister for Health on the development and conduct of clinical research in Victoria. He is a Director of the Asia Pacific Collaborative Study Group and a member of the Executive of the American Cardio Renal Society.
His formal qualifications include his basic medical degree from the University of London (1981) and his subsequent Doctorate of Medicine from the University of Melbourne (1989).
Professor David Power
Professor Power is Director of Nephrology, Austin Health, Heidelberg, Victoria and a Professorial Fellow, Department of Medicine, University of Melbourne. He is the recipient of multiple competitive research grants from the Medical Research Council (UK) and the National Health and Medical Research Council (Australia) and author of over 150 peer-reviewed scientific publications. David has always worked as a clinician, and is actively involved in the clinical management of patients with kidney disease, mainly in the Department of Nephrology at Austin Health.
Professor Power graduated MB BS from the University of Western Australia in 1976. During postgraduate training the United Kingdom and Australia, he received MD and PhD degrees obtained by thesis from the Universities of Aberdeen and Melbourne, respectively.
Daniel Cattran, MD
Dr Cattran is currently a Professor of Medicine at the University of Toronto and a Senior Scientist at the Toronto General Research Institute. His administrative roles have included Chairman of the Royal College of Canada specialty program in nephrology, and director of the PGE program in nephrology at the University of Toronto. He was co-chairman of the KDIGO working group that developed the published guideline for glomerulonephritis management. He was the principle organizer and remains the Chair of the Toronto Glomerulonephritis Registry, which currently includes over 12,000 cases of biopsy proven GN. He has authored over 200 peer-reviewed papers and more than 30 book chapters related in large part to glomerulonephritis.
Dr. Cattran is a graduate of the University of Toronto Medical School. He did postgraduate training both in Toronto, Canada and Sydney, Australia.
Alessia Fornoni, MD, PhD, FASN
Dr. Fornoni is tenured Professor of Medicine and Molecular and Cellular Pharmacology at the University of Miami Miller School of Medicine. She is the Chief of the Division of Nephrology and Hypertension and serves as and Director and Chair of the Peggy and Harold Katz Drug Discovery Center. She is also the Associate Director of the MD PhD program. Dr. Fornoni gained experience in drug development as Global Head of Discovery in Cardiovascular and Metabolism at Hoffman-La Roche in Basel.
She is currently the Vice-President and Chief Scientific Officer of L&F Health LLC, a small start-up company focused on finding a cure for patients affected by chronic kidney diseases. As a physician- scientist who has maintained a resolutely focused research program that has provided novel and seminal contributions to our understanding of the pathogenesis of kidney disease, her research has been supported by grants from National Institutes of Health, industry and private foundations.
Jonathan Hogan, MD
Dr. Hogan is Clinical Director of the Penn Glomerular Disease Center, and Assistant Professor of Medicine, Division of Nephrology, at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, PA, USA. He received his medical education at the University of Pennsylvania School of Medicine in Philadelphia, followed by a residency in internal medicine at the Hospital of the University of Pennsylvania, a Nephrology Fellowship at New York-Presbyterian/Columbia University Medical Center, and a fellowship in glomerular diseases at the Columbia University Glomerular Center.
His expertise includes glomerular diseases (including vasculitis, lupus nephritis, nephrotic syndrome, and FSGS), onconephrology (kidney disease in patients with cancer), and paraprotein-associated kidney diseases. Dr. Hogan is a nationally-recognized expert in these conditions, has published more than 25 papers in peer reviewed medical journals, and given invited lectures on these topics at regional and national meetings. Dr. Hogan is a member of the American Society of Nephrology, the Cure Glomerulopathy Network, NephCure Kidney International and the International Kidney and Monoclonal Gammopathy Workgroup.
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 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. 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 (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 CKD 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 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.
