Slide 1: A clinical-stage drug development company: Corporate Update – Interim study update
A clinical-stage drug development company Corporate Update – Interim study update Wednesday 12 October 2016
Slide 2: Quick overview
Quick overview Key Assets Corporate Snapshot Who we are: A clinical-stage drug development company ASX Code: DXB focused on discovering and developing new therapeutic Share Price (10 Oct): $.011 treatments identified using our proprietary drug discovery Market cap: $16.5m platform. Cash (30 Jun 16):
Slide 3: DMX-200 – Why kidneys?
DMX-200 – Why kidneys? Dimerix identified DMX-200 using Receptor-HIT Irbesartan Propagermaniu (Irb) m (PPG) AT1R CCR2 Off-patent Available for use blockbuster as an anti- treatment of high inflammatory agent blood pressure – CCR2 mediated Both receptors expressed in the kidney • Published pre-clinic
Slide 4: Dimerix lead program – Why kidneys?
Dimerix lead program – Why kidneys? Chronic Kidney Disease (CKD) – the big opportunity • A global unmet medical need leading to kidney failure, cardiovascular disease and premature death • Estimated 26 million people in the US • Estimated US$2.6 billion spent in the US each year, mainly on late stag
Slide 5: FSGS renal survival rates
FSGS renal survival rates Cumulative percentage renal survival in primary FSGS Percent survival; From: Nephrol Dial Transplant (1999) 14 [Suppl. 3]: 68-73 Non Nephrotic Proteinuria: 0.3–3 g protein/day (PCR – 30-300 mg/mmol) Nephrotic proteinuria: >[3-3.5] g protein/day (PCR > 300-350 mg/mmol) Massi
Slide 6: DMX-200 Phase II (Part A) Interim Data
DMX-200 Phase II (Part A) Interim Data • Study is on schedule and recruiting across four sites • A total 21 of 30 participants dosed at end of Q3 2016 • Interim data shows DMX-200 well tolerated with encouraging safety profile • All participants on stable irbesartan dose prior to start of treatment
Slide 7: CKD/FSGS treatment comparables
CKD/FSGS treatment comparables • Phase II asset, sparsentan, for treating FSGS – a • Completed Phase II for CCX140 in diabetic dual angiotensin endothelin receptor blocker nephropathy – a CCR2 antagonist • Patients removed from Standard of Care • Significant improvement in proteinuria on treatment 2
Slide 8: DMX-200: Path to Registration for FSGS
DMX-200: Path to Registration for FSGS Australian Phase II study • Part A: Interim: confirmed safety and signs of efficacy: Reporting mid 2017 • Part B: Efficacy of optimal dose(s): Commencing 2017 US Investigation New Drug (IND) application • Initial pharmacokinetic (PK) study • Comparison of curre
Slide 9: Outlook for next 12–18 months
Outlook for next 12–18 months DMX-200 Program • Complete recruitment for Phase 2 Part A – Q4 2016 • Complete extended release formulation for propagermanium - 1H 2017 • Report Phase 2 dose escalation trial - mid 2017 • Open IND for PK study – mid 2017 • Commence Phase 2 Part B – 2H 2017 DMX-250 Prog
Slide 10: Further Information
Further Information Kathy Harrison, General Manager James Williams, Executive Chairman +61 419 359 149 +61 409 050 519 kathy.harrison@dimerix.com james@dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com
Slide 11: Experienced board and management
Experienced board and management Executive Chairman: Dr James Williams • 15 years experience starting, funding, running and exiting biotechnology companies BSc(Hons), PhD, MBA, • Co-founder of Dimerix and iCeutica (acquired in 2011 and now with 3 FDA drug approvals) GAICD • Co-founder and Investment