Slide 1: Dimerix Corporate Presentation
For personal use only Dimerix Corporate Presentation BioEurope 7th November 2017 1
Slide 2: Disclaimer
Disclaimer For personal use only Some of the information in this presentation may refer to Dimerix Limited (“Dimerix” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all
Slide 3: Dimerix Limited (ASX:DXB)
Dimerix Limited (ASX:DXB) For personal use only 1. Using proprietary “Receptor HIT” drug discovery platform spun out from the University of Western Australia, to identify multiple development programs 2. Lead program is DMX-200 in Phase 2 human trials for Chronic Kidney Disease (CKD) • Uses compound
Slide 4: Important CKD indications – FSGS and Diabetic Nephropathy
Important Chronic Kidney Disease (CKD) indications – FSGS and Diabetic Nephropathy For personal use only Focal segmental glomerulosclerosis (FSGS) Diabetic nephropathy (DN) • FSGS is characterized by proteinuria, • Diabetic nephropathy is the single most nephrotic syndrome and rapid progression to c
Slide 5: Dimerix has identified distinct synergy between CCR2 and AT1R
Dimerix has identified distinct synergy between between CCR2 and AT1R For personal use only Receptor Heteromer: Macromolecular complex composed of at least two (functional) receptor units with biochemical properties that are demonstrably different from those of its individual components. Ferre et al
Slide 6: DMX-200 – Dimerix lead program for CKD
DMX-200 – Dimerix lead program for CKD For personal use only • DMX-200 is a tablet which is taken in conjunction with existing medications. • Patients continue taking their standard of care medication (irbesartan) and add a second drug to this (propagermanium), a CCR2 antagonist. • This has been con
Slide 7: Phase 2a Study Summary
DMX-200 Phase 2a Study Summary For personal use only The graph shows individual patient PCR** values as % change from baseline value during treatment ranked by PCR reduction level. 100 Positive PCR movements highlight possible disease progression during the study 50 ** Δ% PCR from baseline Responder
Slide 8: Primary and Secondary end points
Primary and Secondary end points For personal use only Primary Endpoint Met: DMX-200 was safe and well tolerated • Adverse events consistent with underlying patient population • No changes in the rate or severity of adverse events with propagermanium. • No clinically significant trends in safety sig
Slide 9: Post hoc analysis – average PCR and ACR in Diabetic Nephropathy Group
Post hoc analysis – average Protein Creatinine Ratio (PCR) and Albumin Creatinine Ratio (ACR) in Diabetic Nephropathy Group For personal use only • 50% (5/10) of diabetic nephropathy patients showed a greater than 50% reduction from baseline in PCR during treatment. • These compelling data justified
Slide 10: Post hoc analysis – average PCR and ACR in Diabetic Nephropathy Group
Post hoc analysis – average Protein Creatinine Ratio (PCR) and Albumin Creatinine Ratio (ACR) in Diabetic Nephropathy Group For personal use only • Diabetic nephropathy patients had a statistically significant mean reduction in PCR of 31.9% between baseline and the last two periods of treatment (p=0
Slide 11: A pipeline in a program – glomerular diseases with an inflammatory component
DMX-200 – a pipeline in a program – glomerular diseases with an inflammatory component For personal use only Development Path by CKD sub- Pre clinical Observational Phase 1 Phase 2a Phase 2b Phase 3 group (indications) Orphan path/ out FSGS* license Out license Diabetic Nephropathy** Orphan path/ ou
Slide 12: Phase 2b Study Design
DMX-200 Phase 2b Study Design • Double blind, placebo controlled For personal use only • Three patient groups: DN(n=60), FSGS plus IgAN (n=30), for total Indicative cohort schedule N=90 • 3-month run-in to ensure stable disease prior to randomisation Baseline Treatment • Patients randomised to 6-mon
Slide 13: Medical advisory board
DMX-200 Medical advisory board For personal use only David Packham – Chair David Power • Director of the Melbourne Renal Research Group. • Director of Nephrology at Austin Health and Professorial • More than 30-years experience participating in over Associate at the University of Melbourne. 40 inter
Slide 14: Intellectual Property
DMX-200 Intellectual Property For personal use only • Dimerix has granted patents in the USA, Australia and Japan covering the lead program DMX-200 (US patent no 9,314,450); and pending applications in Europe and other major jurisdictions including • The ‘450 patent covers the use of CCR2 antagonist
Slide 15: Significant next steps
Significant next steps For personal use only ü Human pharmacokinetics (PK) study to optimise dose of DMX-200 for extended release formulation on track to complete 2H CY2017 (3 tablets daily reduced down to 2 tablets daily) ü Commencement of Phase 2b trial (recruiting Q1 calendar 2018) ü Phase 2a dat
Slide 16: Contact
For personal use only Contact Kathy Harrison Chief Executive Officer +61 419 359 149 kathy.harrison@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com