Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (July 2017)
18 slides from Dimerix's investor presentation, Jul 12, 2017
Slide 1: DMX-200 Phase 2a trial
For personal use only DMX-200 Phase 2a trial Strong safety and encouraging efficacy signals Investor presentation 12 July 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: Presentation highlights
Presentation highlights Dimerix Limited (ASX:DXB) For personal use only 1. .Phase 2a clinical trial for Chronic Kidney .Disease (CKD) now .complete in 27 .patients 2. .Phase 2a results • primary endpoint of safety and .tolerability met • encouraging efficacy data (secondary endpoint) – deemed .clini
Slide 4: Chronic kidney disease (CKD)
Chronic kidney disease (CKD) • CKD is a growing global health problem affecting For personal use only over 13% of Australians, 14% of Americans. • Growing in incidence due to large number of people living with obesity and diabetes. • Damaged kidneys “leak” proteins into the urine. This is called pro
Slide 5: DMX-200 – lead program
DMX-200 – lead program For personal use only • DMX-200 is an ‘adjunct’ therapy, which makes the development path less complex. • Patients continue taking their standard of care medication (irbesartan) and add a second drug to this (propagermanium), which targets inflammation in the kidney. • Both dr
Slide 6: Phase 2a Trial Protocol
Phase 2a Trial Protocol For personal use only • 27 patients in an open label dose escalation study across 4 sites in Australia. • Patients were on stable irbesartan prior to and throughout the study. • Each patient received an oral dose of DMX-200, which was escalated at four week intervals, unless
Slide 7: Phase 2a trial primary endpoint met
Phase 2a trial primary endpoint met • Primary endpoint met – no serious safety concerns For personal use only were observed. • The clinically relevant safety measures were blood pressure (hypertension / hypotension), eGFR (a measure of renal failure) and serum potassium (hyperkalaemia). There were n
Slide 8: Trial outcomes – secondary endpoints
Trial outcomes – secondary endpoints For personal use only • 6 of the 24 patients to complete the study achieved >50% reduction in proteinuria during at least one dose level of propagermanium. • This is a 50% improvement over and above the patients’ stable improvement on standard of care medication
Slide 9: Post-hoc analysis
Post-hoc analysis For personal use only • Three further patients, after dosing ceased, saw an increase in proteinuria of 50% or greater, compared to their final measure on treatment. • This increase suggests that DMX-200 may have had a possible benefit in slowing the disease progression in these pat
Slide 10: Phase 2a trial outcomes – Special Access Scheme
Phase 2a trial outcomes – Special Access Scheme For personal use only • Of the 24 patients to complete the study,11 (45%) applied for and were granted special access to the treatment, upon recommendation of their physician. • The physicians’ recommendation was based on patients meeting one or more o
Slide 11: Response from clinicians
Response from clinicians For personal use only “These are very encouraging data. DMX-200, and its combination with existing best therapy, appears safe and was well tolerated. A 50% additional fall in proteinuria is a ‘high bar’ to set in studies of this type and the observation of this efficacy endp
Slide 12: Phase 2a trial outcomes – summary
Phase 2a trial outcomes – summary For personal use only • Primary end point met – no serious safety concerns were observed. • Secondary end point encouraging – efficacy – 6 of 24 patients classified as “responders” (>50% reduction in proteinuria clinically meaningful). • Trial data can now be used t
Slide 13: Next steps and newsflow
Next steps and newsflow For personal use only 12 months news flow • Human pharmacokinetics study on track to complete 2H CY2017. • Completion of commercial dosage form • Phase 2b – to explore efficacy in refined • Completion of human patient population using optimal doses pharmacokinetic study ident
Slide 14: DMX-200 Development & licensing timeline
DMX-200 Development & licensing timeline For personal use only Activity Q2 Q3 Q4 2018 2019 2020 2017 2017 2017 Phase 2a ü Manufacture of commercial tablet Human PK study - commercial tablet Phase 2b End of Phase 2 consultation with FDA Single pivotal Phase 3 Licensing opportunities Current developme
Slide 15: Competitive landscape for FSGS
Competitive landscape for FSGS For personal use only • NASDAQ: RTRX • NASDAQ: CCXI • Market cap : ~US$ 674million • Market Cap: ~US$ 355 million • Phase 2 asset, sparsentan, for treating • Completed Phase 2 for CCX140 in FSGS – a dual angiotensin endothelin diabetic nephropathy – a CCR2 receptor blo
Slide 16: Dimerix Receptor-HIT platform
Dimerix Receptor-HIT platform For personal use only Receptor-HIT • Patented tool that enables understanding of receptor interactions • Particularly suited to GPCRs – most targeted receptor class for drug discovery • Can identify new uses for existing drugs and drive the discovery of new drugs and re
Slide 17: Corporate Overview
Corporate Overview For personal use only Corporate Snapshot Share price history ASX Code: DXB Share Price (5 Jul 17): $.011 0.02 Market cap: $20.6m Cash (31 Mar 2017): $2.8m Shares on issue*: 1,829.9m 0.01 Major Shareholders Mr Peter Meurs 17.33 0.00 Yodambao Pty Ltd 5.11 Mrs Wishney Sritharan Krish
Slide 18: 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