Dimerix Limited · ASX:DXB
Dimerix — Bio-Europe 2019 Conference
47 slides from Dimerix's conference presentation, Nov 11, 2019
Slide 1: Bio-Europe 2019 Conference Presentation
For Immediate Release Bio-Europe 2019 Conference Presentation For personal use only MELBOURNE, Australia, 11 November 2019: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company, is pleased to provide a copy of the presentation from the Bio-Europe 2019 Conference. For further inform
Slide 2: For personal use only
FSGS is a serious and rare disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and kidney failure and for which there is a recognised medical need for a new or improved treatment. FSGS affects both children and adults. DMX-200
Slide 3: Dimerix Overview
For personal use only Dimerix Overview November 2019
Slide 4: Forward looking statements
Forward looking statements For personal use only This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Dimerix to be ma
Slide 5: Agenda
Agenda For personal use only 1. Introduction to Dimerix 2. Receptor-HIT 3. DMX-200 in Diabetic Kidney Disease 4. DMX-200 in Focal Segmental Glomerulosclerosis (FSGS) 4. DMX-700 in Chronic Obstructive Pulmonary Disease (COPD) 5. Summary 3
Slide 6: About Dimerix
About Dimerix For personal use only In pre-clinical studies Public DMX-700 in company COPD (ASX: DXB) Receptor-HIT Phase 2 in platform diabetic licensed kidney Formed in globally disease (non-exclusive) Two further 2004 on Late Phase 2 Phase 2 trials proprietary licensing underway for GPCR assay opp
Slide 7: A pipeline of drugs identified using Receptor-HIT
A pipeline of drugs identified using Receptor-HIT For personal use only Programs based on the critical scientific rationale Strategic Fit that GPCRs act as a complex with other GPCRs and have novel pharmacology when in complex • Dimerix is developing a commercial pipeline of drugs for G Protein-Coup
Slide 8: Development pipeline
Development pipeline For personal use only 3 product candidates in the pipeline, with 2 clinical read outs expected in 2020 Pivotal Study Preclinical Phase 1 Phase 2 Market Compound Disease Target Focal Segmental Glomerulosclerosis Phase 2 readout mid-2020 DMX-200 (FSGS) Phase 2 readout mid-2020 DMX
Slide 9: Introduction to Receptor-HIT
For personal use only Introduction to Receptor-HIT
Slide 10: Evolution of GPCR drug discovery
Evolution of GPCR drug discovery For personal use only G Protein-Coupled Receptors • A large family of cell surface receptors • Involved in most processes in the body – normal and disease state • GPCRs are the target of 30-40% of all known drugs • Discovery led to 2012 Nobel Prize for Chemistry for
Slide 11: Dimerix technology – Receptor-HIT
Dimerix technology – Receptor-HIT For personal use only • Patented tool that enables understanding of real-time receptor interactions • Particularly suited to GPCRs • Can identify new uses for existing drugs, deorphanize receptors, and drive the discovery of new drugs and research programs Receptor
Slide 12: Discovery of DMX-200 – Receptor-HIT at work
Discovery of DMX-200 – Receptor-HIT at work For personal use only Using proprietary discovery platform Receptor- HIT, Dimerix identified: i) Formation of AT1R and CCR2 heteromers; ii) Novel pharmacology (potentiation of signaling) iii) Dual blockade of AT1 receptor and CCR2 is required for total inh
Slide 13: Introduction to DMX-200
For personal use only Introduction to DMX-200
Slide 14: What is DMX-200
What is DMX-200 For personal use only DMX-200: a small molecule known as propagermanium for patients already receiving angiotensin receptor blockade NCE status • Twice daily, capsule administration in US and • Administered to patients already on standard of care treatment (irbesartan) Europe • Produ
Slide 15: DMX-200 proposed mechanism of action
DMX-200 proposed mechanism of action For personal use only DMX-200 addresses three key mechanisms that causes renal damage and chronic kidney disease 1 hyperfiltration of and hypertension within blood Irbesartan blocks cellular receptors responsible for hyperfiltration vessels of the & glomerular hy
Slide 16: Competitive advantage
Competitive advantage For personal use only DMX-200 compares favourably to compounds currently in development: Current standard of care (AT1R blocker) • Strong, superior efficacy data Large unmet need in growing market • Known safety profile with no adverse events seen Lower risk development 14
Slide 17: Clinical experience
Clinical experience For personal use only 1 x Phase 1 study (DMX-200-101) 1 x Phase 2a study (DMX-200-201) pharmacokinetic and safety Safety, tolerability study, and clinical study efficacy study 15
Slide 18: DMX-200 Phase 2a results summary (N=27)
DMX-200 Phase 2a results summary (N=27) Safety and tolerability of DMX-200 as an adjunct therapy to For personal use only irbesartan treatment in patients with proteinuric kidney disease Primary Endpoints (“safety”) Secondary Endpoints (“efficacy”) • Incidence and severity of Adverse Events • The pr
Slide 19: DMX-200 Phase 2a study
DMX-200 Phase 2a study Diabetic sub-group ACR mean reduction (n=10) For personal use only • In 2001 - Irbesartan studied in a large group of type 2 diabetics • Proteinuria levels reduced by 24% Δ% ACR from baseline (SD) • In 2017 - DXB Phase 2a study: DMX- 200 + Irbesartan In addition to irbesartan
Slide 20: CMC overview
CMC overview For personal use only USA based contract manufacturer appointed for commercial supply of API FDA approved manufacturing facility Exclusive development and methodology to manufacture API owned by Dimerix In-house capability for commercial supply of finished product Analytical m
Slide 21: DMX-200 regulatory overview 505(b)(1)
DMX-200 regulatory overview 505(b)(1) regulatory pathway For personal use only for New Chemical Entity (NCE) IND submission planned planned in 2020, post Phase 2 data read-out Pre-IND meeting scheduled November 2019 for FSGS Phase 3 plan Significant literature based non-clinical data available to su
Slide 22: Intellectual Property
Intellectual Property For personal use only Patents • Multiple granted patents in numerous territories • New patent applications underway in line with commercialisation strategy • Granted method of use patents in key territories strengthens the company's competitive position • Granted patents may bl
Slide 23: DMX-200 in Diabetic Kidney Disease
For personal use only DMX-200 in Diabetic Kidney Disease
Slide 24: DMX-200 proposed indication
DMX-200 proposed indication For personal use only for the treatment of diabetic nephropathy FDA in patients with type 2 diabetes 22
Slide 25: Market dynamics: Diabetic Kidney Disease
Market dynamics For personal use only Diabetic Kidney Disease • Also known as Diabetic Nephropathy • 23 million diagnosed diabetics in the US* • Dialysis costs of ~$100,000/patient/year¥ 36.5% of these had kidney disease* ~8.3 million with Diabetic Kidney Disease in the US alone • Dialysis sever
Slide 26: DMX-200 for Diabetic Kidney Disease value in US
DMX-200 for Diabetic Kidney Disease value in US: large market with low competition For personal use only Irbesartan 300mg administered to patients for kidney disease Branded product retail price US$590* per month 4.05 million scripts for irbesartan 300mg >50% of patients (1 month supply) taking irbe
Slide 27: Phase 2 trial in Diabetic Kidney Disease
Phase 2 trial in Diabetic Kidney Disease For personal use only Phase 2 DMX-200-203 (ACTION for DKD)- A Phase 2, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Diabetic Kidney Disease (DKD) who are Receiving Irbesart
Slide 28: Phase 2 trial in Diabetic Kidney Disease
Phase 2 trial in Diabetic Kidney Disease For personal use only • Double-blind, randomised, placebo-controlled, crossover study evaluating the safety and efficacy of DMX- 200 in patients with diabetic kidney disease who are receiving a stable dose of Irbesartan Study period 1 Washout Study Period 2 1
Slide 29: Phase 2 trial in Diabetic Kidney Disease
Phase 2 trial in Diabetic Kidney Disease For personal use only Primary Secondary endpoint endpoints Percent change from baseline in 24- • Assessment of frequency of patients who achieve an albuminuria- hour ACR after 11/12 weeks of based response during treatment (reduction of ≥ 30% geometric treatm
Slide 30: Development timelines
Development timelines For personal use only 2019 DKD - complete Partnering activities recruitment and discussions Communicate Manufacture with FDA commercial GMP batch Continue progress 2020 with licensing partner DKD topline data available Q2CY20 28
Slide 31: Summary
Summary For personal use only DKD is a large & growing market Unmet need, with low competition Granted patents with additional patents pending Strong existing Phase 2a data demonstrating superior efficacy Existing long-term safety data available Reduced risk and development program Pro
Slide 32: Introduction to DMX-200 in FSGS
For personal use only Introduction to DMX-200 in FSGS
Slide 33: DMX-200 proposed indication
DMX-200 proposed indication For personal use only FDA for the treatment of focal segmental glomerulosclerosis 31
Slide 34: Market dynamics: Focal Segmental Glomerulosclerosis
Market dynamics For personal use only Focal Segmental Glomerulosclerosis • A serious and rare kidney disease: orphan indication • Rapid progression to end-stage renal disease • Dialysis costs of ~$100,000/patient/year • ~210,000 individuals globally • Eventually require blood dialysis • Dialysis sev
Slide 35: DMX-200 for FSGS value in US
DMX-200 for FSGS value in US: orphan drug status with low competition For personal use only ~10% of patients 210,000 FSGS Average with a rare disease sufferers globally# orphan drug pricing are treated with an 120,000 estimated in >US$7,000 approved orphan the US per month* drugǂ Potential addressab
Slide 36: Phase 2a trial in FSGS
Phase 2a trial in FSGS For personal use only Phase 2a DMX-200-202 (ACTION for FSGS)- A Phase 2a, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Primary Focal Segmental Glomerulosclerosis who are Receiving Irbesartan
Slide 37: Phase 2a trial in FSGS
Phase 2a trial in FSGS For personal use only • Double-blind, randomised, placebo-controlled, crossover study evaluating the safety and efficacy of DMX- 200 in patients with primary FSGS who are receiving a stable dose of Irbesartan Study period 1 Washout Study Period 2 16 weeks 6 weeks 16 weeks Resu
Slide 38: Phase 2a trial in FSGS
Phase 2a trial in FSGS For personal use only Primary Secondary endpoint endpoints The Number of Adverse Events with • Percent change from baseline in 24-hour PCR after 16-weeks of the Adjunct use of Propagermanium treatment with propagermanium as compared to placebo (mean Compared to Placebo in Part
Slide 39: Development timelines
Development timelines For personal use only 2019 FSGS - complete Partnering activities recruitment and discussions Communicate Manufacture with FDA commercial GMP batch Continue progress 2020 with licensing partner FSGS topline data available Q2CY20 37
Slide 40: Summary
Summary For personal use only FSGS is a small but growing market Orphan status with FDA and EMA Unmet need, with no current competition Granted patents with additional patents pending Existing long-term safety data available Reduced risk and development program Product supply at commer
Slide 41: Introduction to DMX-700 in COPD
For personal use only Introduction to DMX-700 in COPD
Slide 42: What is COPD?
What is COPD? 4th leading cause of death worldwide For personal use only DMX-700 in Chronic Obstructive Among the top 5 Pulmonary Disease No cure available & causes of death, (COPD) existing treatments COPD is the only aimed at relieving Progressive & life- one with threatening lung symptoms only di
Slide 43: COPD landscape
COPD landscape For personal use only Global Initiatives Global COPD • World Health Organization (WHO) treatment market No candidates in • COPD Foundation US$14 billion (2017) & projected to late stage • American Thoracic Society increase at CAGR development • Centers for Disease Control & Prevention
Slide 44: Introducing DMX-700 for COPD
Introducing DMX-700 for COPD For personal use only • DMX-700 for the treatment of COPD by blocking heteromer signalling in receptors active in COPD • Initial studies on the receptor pair have been conducted under an Innovation Connections grant awarded to Dimerix in November 2018 • The two molecules
Slide 45: DMX-700 proposed mechanism of action
DMX-700 proposed mechanism of action For personal use only Certain lung cells express both receptors, thus blocking only one receptor does not block signalling and results in only a partial response to treatment DMX-700 blocking both receptors simultaneously to provide a more complete response to tr
Slide 46: DMX-700 pre-clinical data
DMX-700 pre-clinical data When both Receptor For personal use only ligands administered More than additive signal observed When only Receptor 2 ligand administered: larger signal observed When only Receptor 1 ligand administered: signal observed Ligands administered DMX-700 targets blocking both rec
Slide 47: End of Presentation
For personal use only DIMERIX End of Presentation Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com