Investors and people curious about DXB and considering investment, heres a quick overview - We are waiting for DMX-200 results
This is to add or supplement other posters information -
We must be getting very close to results now- as we only have approx. 8 trading days before end of September AND results to be reported to market in Q3 2016 - Could be any day now and if its shown to be safe and highly efficient we are on a winner and whats exciting about that is that we could eventually enter the Orphan Pathway- which essentially enables much shorter trials and less patents required meaning less money etc...
A quick snapshot about DXB !!
Whats the opportunity
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 stage therapies due to lack of early stage treatment options The Orphan Pathway
• Enables shorter trials with fewer patients and cost benefits
• Registration brings seven years of exclusivity in the US market
Current Phase 2 POC – Part A
• Treatment of proteinuria in chronic kidney disease (CKD) patients taking irbesartan
• Dose escalation to show safety and inform best dose of propagermanium
• Recruitment on target
• Initial safety and efficacy data to be reported Q3 2016
DMX-200 – Path to Registration for FSGS
US Investigation New Drug (IND) application
• Initial pharmakokinetic (PK) study
• Comparison of current three times daily version with extended release formulation
Phase 3 Development for FSGS – FDA Pre-IND meeting outcomes:
• Agreed development as a adjunct (not combination) therapy
• Primary endpoint discussions positive:
“A substantial change in proteinuria in patients with marked proteinuria
at baseline may be an acceptable endpoint for traditional or accelerated
approval…”
WHAT ELSE IS DXB WORKING ON ?
DMX-250
– NASH 10 The opportunity • Non–Alcoholic Steatohepatitis (NASH) is a serious unmet medical need • Estimated 6 million people in the USA alone • Increasing incidence due to increasing obesity, diabetes and metabolic diseases • Estimated global market size by 2020: >US$1 billion
DMX-250 – Why Liver?
DMX-250
• Both the Angiotensin Receptor and the Chemokine 2 Receptor associated with liver
disease
• Builds on the knowledge from DMX-200 of the CCR2 antagonist propagermanium
• Investigating Angiotensin Receptor Blockers other than irbesartan for commercial
differentiation
Patents
Good to see Kathy Harrison (General Manager) is also a Registered Patent and Trade Mark Attorney which bodes well for us -
Management Team - the calibre is OUTSTANDING
Experienced board and management Executive Chairman: Dr James Williams BSc(Hons), PhD, MBA, GAICD
• 15 years experience starting, funding, running and exiting biotechnology companies
• Co-founder of Dimerix and iCeutica (acquired in 2011 and now with 3 FDA drug approvals)
• Co-founder and Investment Director of Yuuwa Capital ($40M venture capital fund)
Director: Dr Sonia Poli MSc, PhD • Former Senior Management at Hoffman la Roche and Executive at Addex Therapeutics (Switzerland)
• 20 years international experience in small molecule drug design, optimization and clinical development
• Expertise encompassing multiple therapeutic areas.
Director: Dr Liz Jazwinska PhD, MBA, GAICD
• 25 years experience in R&D management and drug portfolio business development
• Led Asia Pacific Partnering Group at Johnson and Johnson Research
• Director Industry Engagement at Institute of Medical Biology, A*STAR,
Singapore Director: Mr David Franklyn BEcon
• Experienced Director of ASX-listed companies in a variety of sectors
• Extensive experience in financial analysis, corporate advice, business management and IR
• Managing Director of Village National Holdings Limited
General Manager: Ms Kathy Harrison MSc, Cert.Gov.(Prac), FIPTA
• 20 years experience in Biotech: AMRAD, Cytopia Research Pty Ltd, Phosphagenics Limited
• Registered Patent and Trademark Attorney
Exciting times for a massive re-rate in relation to our peers at stage 2 and 3 trials who are way above our small market cap
(20min delay)