Slide 1: DMX-200 Phase 2a Data
For personal use only Dimerix DMX-200 Phase 2a Data 3rd 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: Company strategy
Company strategy Dimerix Limited (ASX:DXB) For personal use only 1. Using proprietary “Receptor HIT” drug discovery platform to identify multiple development programs 2. Lead program is DMX-200 in Phase 2 human trials for Chronic Kidney Disease (CKD) • Uses compounds that are already known • Orphan
Slide 4: Corporate overview
Corporate overview For personal use only Corporate Snapshot ASX Code DXB# Share price history Share Price (25 Oct 17) $0.185 Market cap $17m Cash (30 Sep 2017) $1.6m (R&D tax incentive, $545,771 received 17th October 2017) Shares on issue* 91.9m Major Shareholders (%) Mr Peter Meurs 17.33 Yodambao P
Slide 5: Experienced board and management
Experienced board and management For personal use only Dr James Williams – Chairman Hugh Alsop – Director • Co-founder of Dimerix and iCeutica (acquired • Accomplished and commercially-focused in 2011 and now with 3 FDA drug approvals) pharmaceutical and biotechnology executive • Co-founder and Inve
Slide 6: Medical advisory board
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 international
Slide 7: Chronic kidney disease (CKD) - market opportunity
Chronic kidney disease (CKD) - market opportunity For personal use only • CKD is a global health problem affecting over 10% of the population with 26 million patients in the US alone • CKD can be cause by a number of different types of disease, or be of unknown cause • CKD gets progressively worse,
Slide 8: Important sub-group indications of CKD – FSGS and Diabetic Nephropathy
Important sub-group indications of CKD – 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 common cause of
Slide 9: Current treatments for CKD
Current treatments for CKD For personal use only • Damaged kidneys “leak” proteins into the urine. This is called proteinuria and is the most common symptom of kidney disease – relevant measure of treatment efficacy (a prognostic indicator of future kidney damage). • First line therapy is reducing b
Slide 10: Comparator Programs
Comparator Programs For personal use only • NASDAQ: CCXI • NASDAQ: RTRX • Market Cap: ~US$329 million • Market cap : ~US$ 917 million • Completed Phase 2 for CCX140 in diabetic • Phase 2 asset, sparsentan, for treating nephropathy (a CKD sub-group indication)– FSGS (a CKD sub-group indication) – a d
Slide 11: 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 12: Study Summary
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 movements 0 • 13
Slide 13: 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 14: 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 15: 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 16: DMX-200 – a pipeline in a program
DMX-200 – a pipeline in a program 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 license FSGS Out license Diabetic Nephropathy Orphan path/ out license IgA Nephropathy Out License Diabetic Retinopat
Slide 17: Trial design and Choice of FSGS, DN and IgA
Trial design and Choice of FSGS, DN and IgA For personal use only • Glomerular diseases with an inflammatory component • FSGS an Orphan indication, faster path to market and compelling license opportunity • Diabetic Nephropathy an enormous market potential and compelling data from Phase 2a (greatly
Slide 18: DMX-200 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 19: DMX-200 Phase 2b Study Endpoints
DMX-200 Phase 2b Study Endpoints For personal use only Primary Endpoint Secondary Endpoints Exploratory Endpoints • Change in 24-hour ACR from • Incidence and severity of AEs • Steady-state plasma PK baseline (mean of run-in) to the throughout study • Change in PCR, eGFR and total end of treatment (
Slide 20: DMX-200 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 21: 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 Presentation of Phase 2a data by CEO Kathy Harrison at BioEurope on 7th Nov
Slide 22: 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
Slide 23: Additional Details
For personal use only Additional Details
Slide 24: FSGS: An orphan disease with limited treatment options
FSGS: An orphan disease with limited treatment options For personal use only • Focal segmental glomerulosclerosis (FSGS) is a group of clinical-pathological syndromes sharing a common glomerular scarring lesion and characterized by proteinuria, nephrotic syndrome and rapid progression to end-stage r
Slide 25: Diabetic Nephropathy
Diabetic Nephropathy For personal use only Treatment and Referral Algorithm • Diabetic nephropathy is the single most common cause of chronic Type 1 Type 2 Diabetes Diabetes kidney disease worldwide and is associated with significant increase in cardiovascular morbidity and mortality • US prevalence
Slide 26: Study Design Phase 2a
Study Design Phase 2a For personal use only Primary Objectives Secondary Objectives • To determine the safety and tolerability of propagermanium when added to • To evaluate the effects of propagermanium on various biomarkers when standard irbesartan treatment in participants with proteinuria added t
Slide 27: Phase 2a Primary end point - safety
Phase 2a Primary end point - safety For personal use only • Combined therapy with propagermanium and irbesartan was well tolerated. • Adverse events were consistent with underlying patient and population co-morbidities. • There was no change in the rate of AEs or severity of AEs with dose of propage
Slide 28: Phase 2a Secondary Pre Specified Endpoint - Proteinuria
Phase 2a Secondary Pre Specified Endpoint - Proteinuria • 24 patients completed dosing and were assessed for efficacy. For personal use only • 6 patients achieved the pre-specified criteria of responders: “participants achieving normalization of proteinuria or a 50% reduction in proteinuria”. • Resp
Slide 29: Phase 2a Post hoc analysis
Phase 2a Post hoc analysis For personal use only • 50% (5/10) of diabetic nephropathy patients showed a greater Reduction in PCR (24-hr) of diabetic nephropathy patient cohort (n=10) during combined treatment with irbesartan and propagermanium. than 50% reduction from baseline in PCR (24-hr) during
Slide 30: DMX-200 Phase 2b Key Inclusion Exclusion Criteria
DMX-200 Phase 2b Key Inclusion Exclusion Criteria For personal use only General Inclusion General Exclusion • Adults > 18 to 75 years • Use of an ACE or symptomatic use of • BMI 20-40 kg/m2 immunomodulatory agents including steroids • Proteinuric disease > 6 months duration • Previous renal transpla
Slide 31: DMX-200 US IP and data exclusivity strategy for FSGS
DMX-200 US IP and data exclusivity strategy for FSGS *assumed DMX-200 For personal use only registration for FSGS 2022 * 2017 2018 2019 2020 2021 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 Possible max 4 year Combination Therapy Patent patent extension Paten