MELBOURNE, Australia, 06 May 2016: Dimerix Limited (ASX: DXB), a clinical-stage biotechnology Company committed to discovering and developing new therapeutic treatments identified using its proprietary screening assay, today announced the Australian Research Council (ARC) had awarded a AUD$499,000 Linkage Grant to a consortium that includes Dimerix working with the Harry Perkins Institute of Medical Research and The University of Western Australia (UWA).
The grant entitled ‘Development of Technologies to Monitor Multimolecular Complexes’ will be paid over three years and will expedite development of Dimerix’s discovery platform in new ways for new applications.
The UWA consortium is led by Dimerix’s Chief Scientific Advisor, Associate Professor Kevin Pfleger (UWA and Harry Perkins Institute of Medical Research), working with other key scientists at the University of Queensland, University of Nottingham (UK), leading instrumentation manufacturer BMG Labtech and global reagent supplier Promega Corporation, and will enable further development of Dimerix’s discovery platform in new ways for new applications.
Dimerix Executive Chairman, Dr James Williams, a Partner Investigator of the Linkage Grant, said, “These additional funds will enable Dimerix to engage with leaders in the field, to progress the scientific excellence of its discovery assay potential, as well as routes to commercialisation.
“We believe it will further enable Dimerix to make significant progress towards realising the commercial value of its discovery platform capabilities.”
Dimerix has committed AUD$100,000 research funding to support the project, along with in kind commitments of advice and expertise.
Dimerix Bioscience Limited
Dimerix Limited’s wholly owned subsidiary Dimerix Bioscience Limited is a clinical-stage pharmaceutical Company committed to discovering and developing new therapeutic models identified using its proprietary screening 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 and 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 firms.
For more information see www.dimerix.com
DMX-200 combines two existing drugs, irbesartan and propagermanium. 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 for 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 model(1).
The DMX-200 Phase II Trial
The trial is a single arm, open label study in adult patients with chronic kidney disease (with proteinuria). The primary end points are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants. The secondary end points are obtained from statistical analysis of biomarker data at each time point including change from baseline, and the proportion of responders defined as those participants achieving normalisation of proteinuria (proteinuria within normal limits) or those participants achieving a 50 per cent reduction in proteinuria.
The trial has two parts, Part A is a dose escalation trial recruiting up to 30 patients. All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day. Each patient will commence on 30mg PPG/day and the dose increased each 28 days to a maximum of 240mg/day, or until proteinuria is absent or reduced to a level the clinician considers acceptable.
The Company expects to carry out an interim analysis of the Part A data to confirm the safety of the therapy and observe any biomarker changes on up to 15 patients. It is expected interim data will be available during 2016.
Part B is an expansion study, in which up to 30 patients are recruited on the best dose identified from Part A. The Company expects to review the design of Part B in consultation with the FDA and in light of all data available to the Company, prior to commencement of Part B. These discussions will be in line with the Company’s strategy of pursuing registration for an orphan indication in which the sufferers exhibit chronic kidney disease. The Company has achieved orphan designation for Focal Segmental Glomerulosclerosis (FSGS) from the FDA. The trial has commenced at four sites in Melbourne, Australia, and may be expanded into other jurisdictions to meet recruitment targets and regulatory goals.
Chronic Kidney Disease
Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation specifically in the kidneys. Proteinuria is the most common manifestation of the disease. As the disease progresses it can lead to end-stage renal disease (ESRD) where the kidneys fail. The only treatment for ESRD is a kidney transplant or regular blood-cleansing treatments called dialysis. More than 26 million people suffer from the disease in the United States.
(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. eCollection 2015.
Issued for and on behalf of Dimerix by Instinctif Partners.
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Sue CharlesManaging Partner