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DIMERIX LIMITED — Regulatory Filings 2017
Jun 13, 2017
64804_rns_2017-06-13_932888fd-f09f-42b8-b56d-fdfa87f41812.pdf
Regulatory Filings
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For Immediate Release
ASX/Media Release
Interview with Dimerix Chief Executive Officer
MELBOURNE, Australia, 14 June 2016: Dimerix Limited (ASX: DXB), a clinical-stage biotechnology company discovering and developing new therapeutic treatments identified using its proprietary assay technology, today published a recorded interview with Chief Executive Officer Kathy Harrison.
The recent interview highlighted a number of important points including:
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the innovative clinical and commercial development pathway for Dimerix’s lead compound (DMX-200) as a potential new therapy for treating chronic kidney disease
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the global market size and significant unmet medical need for new kidney disease treatments
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the relatively low development and safety risk of Dimerix’s lead drug candidate due to the use of an established drug which has been successfully used for decades, combined with a drug which is the current standard of care for kidney patients.
The full interview is available at http://dimerix.com/interview/
Dimerix is on track to release clinical data from the full cohort of patients for its Phase 2 Dose Escalation study in chronic kidney disease in July 2017. Interim data from the study published in 2016 was positive and well received by clinicians. Dimerix is also on track to initiate a Phase 2 dose expansion study in the second half of 2017.
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For more information please contact:
| At the company | Media (Australia) | Media (International) |
|---|---|---|
| Kathy HarrisonChief Executive OfficerDimerix LimitedTel: +61 419 359 149E: [email protected] | Andrew GeddesTel: +61 408 677 734E: [email protected] | Sue Charles/Daniel GoochTel: +44 (0)20 7866 7905E: [email protected] |
Dimerix Bioscience Pty Ltd
Dimerix Limited’s 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
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DMX 200
DMX-200 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).
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 and completed enrolment at the end of November 2016. 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 complete Part A in mid 2017. Part B is an expansion study, in which up to 30 patients will be given the optimal dose identified from Part A.
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.