Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Conference Presentation (October 2020)
31 slides from Actinogen Medical's conference presentation, Oct 15, 2020
Slide 1: Actinogen Presentation and Planned Conference Call
ASX ANNOUNCEMENT Actinogen Presentation and Planned Conference Call Sydney, 15 October 2020. Actinogen Medical ASX: ACW (‘ACW’ or ‘the Company’) is pleased to advise that Dr. Bill Ketelbey, CEO and MD of Actinogen, will provide an update on the clinical development plans for Xanamem during a confere
Slide 2: About Actinogen Medical
About Actinogen Medical Actinogen Medical (ASX:ACW) is an ASX-listed biotechnology company developing novel therapies for neurological, psychiatric and metabolic diseases associated with chronically elevated cortisol. The company is currently developing its lead compound, Xanamem, as a promising new
Slide 3: Deal Presentation
DEAL PRESENTATION Dr. Bill Ketelbey: CEO & MD October 2020 Developing novel therapies for cognitive impairment and behavioural symptoms due to raised cortisol in chronic neurological, psychiatric, developmental and metabolic diseases
Slide 4: Executive summary
Executive summary Developing XanamemTM for cognitive impairment and behavioural symptoms due to raised cortisol in chronic neurological, psychiatric, developmental and metabolic diseases Xanamem an oral, brain penetrant, selective and effective 11β-HSD1 inhibitor. Comprehensive analysis of the subst
Slide 5: Leveraging development across multiple indications
Leveraging development across multiple indications Xanamem’s strategic development across multiple target indications, complementing Alzheimer's disease with Fragile X syndrome selected as a new priority clinical development opportunity XanaMIA: Phase II trial in FXS selected as next clinical MCI du
Slide 6: Attractive development pipeline
Attractive development pipeline Actinogen is targeting a broad portfolio of clinical indications to assess the efficacy of it’s lead drug, Xanamem Studies 2H CY20 1H CY21 2H CY21 Upcoming catalyst1 Trial to commence XanaMIA: Mild cognitive impairment due to recruitment in 1H CY21 Trial planning Phas
Slide 7: Xanamem – lead compound
Xanamem™ – lead compound Novel Mechanism of Action - designed to inhibit cortisol production in the brain (through inhibition of the 11β-HSD1 enzyme) Compelling results from various studies underpin further clinical development Pre-clinical long-term toxicology studies Phase II trial in Alzheimer’s
Slide 8: Key outcomes from Xanamem studies
Key outcomes from Xanamem studies Xanamem, an oral compound, demonstrated to be an efficacious, safe, brain penetrant, selective and effective 11β –HSD1 inhibitor producing significant pharmacodynamic effects on cortisol Xanamem dose Cognitive Breakthrough results demonstrate a statistically signifi
Slide 9: Target Occupancy study: positive confirmatory data
Target Occupancy study: positive confirmatory data Phase I target occupancy study demonstrates that 5mg to 30mg Xanamem dosed for seven days significantly binds to the neuronal 11β-HSD1 enzyme throughout the brain (32 of 36 patients completed) 50% to 85% occupancy, dependent upon brain region, dosag
Slide 10: MCI due to Alzheimer's disease
MCI due to Alzheimer‘s disease
Slide 11: Alzheimer's disease remains a focus
Alzheimer’s disease remains a focus Market dynamics of Alzheimer's disease presents a compelling commercial opportunity for Actinogen Substantial target market with significant upside1 Underpinned by favourable market dynamics Cognitively Subjective Cognitive and functional decline Targeting large a
Slide 12: Alzheimer's disease – Mild Cognitive Impairment due to AD
Alzheimer’s disease – Mild Cognitive Impairment due to AD XanaMIA – evaluating Xanamem in patients with Mild Cognitive Impairment (MCI) due to AD (an early stage of the AD spectrum), linking the compelling XanaHES results with an Alzheimer’s disease patient population Healthy MCI due to Alzheimer’
Slide 13: Significant cognitive efficacy signal achieved
Significant cognitive efficacy signal achieved New XanaMIA trial to leverage breakthrough XanaHES results1 demonstrate robust statistically significant cognitive efficacy improvement in multiple cognition domains – based on Cogstate Cognitive Test Battery Working memory (One Back Test) Visual attent
Slide 14: XanaMIA - Phase II clinical trial
XanaMIA - Phase II clinical trial XanaMIA: A Phase II trial to demonstrate the safety, tolerability and efficacy of Xanamem 10mg twice daily in patients with MCI due to Alzheimer’s disease Proposed clinical trial design Key milestones Study Phase II proof-of-concept study; double-blind, placebo-co
Slide 15: Fragile X syndrome
Fragile X syndrome
Slide 16: Fragile X syndrome
Fragile X syndrome Fragile X syndrome is a rare genetic condition with behavioural symptoms (including intense anxiety) and cognitive deficit representing a significant unmet medical need with limited treatment options X X FXS is caused by mutations in the Fragile FMR1 X gene (FMR1) of the X chromos
Slide 17: Research supports Xanamem as a FXS treatment
Research supports Xanamem as a FXS treatment Medical and scientific research validates cortisol as a therapeutic target in FXS Raised cortisol associated with stress- Xanamem safely and effectively inhibits induced behavioural problems in FXS cortisol production Biological changes in FXS promotes
Slide 18: Valuable FXS market opportunity
Valuable FXS market opportunity While FXS is a rare disease, anxiety, sleep, and behavioural symptoms in FXS represent substantial commercial opportunities Target population Prevalence Anxiety, sleep, and Approx. 1 in 2500-4000 males behavioural problems and 1 in 7000-8000 females in FXS adolescents
Slide 19: Clinical development underpinned by strategic benefits
Clinical development underpinned by strategic benefits Xanamem in FXS - attractive regulatory, development, and commercial benefits through potential increased speed to market, reduced costs, and enhanced competitive protection Benefits provided by Orphan Drug and Rare Paediatric Disease Designation
Slide 20: XanaFX Phase II clinical trial
Phase II clinical trial XanaFX: A Phase II trial to demonstrate the safety and efficacy of Xanamem on anxiety, sleep, and behavioural problems in adolescent males with Fragile X syndrome Clinical trial design Key upcoming milestones Study design Phase II proof-of-concept study Planned FXS clinical
Slide 21: Outlook
Outlook
Slide 22: Next steps and key catalysts
Next steps and key catalysts Plans for key clinical trials, expected to commence in 1H CY21 Finalise optimal study parameters and trial protocols (4Q CY20) Apply for FXS Orphan Drug and Rare Paediatric Disease Designation Receive regulatory approval and commence next phase of clinical trials (
Slide 23: Disclaimer
Disclaimer This presentation has been prepared by Actinogen Medical Limited. (“Actinogen” 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 information necessary to mak
Slide 24: Appendix A: Corporate background
Appendix A: Corporate background
Slide 25: Corporate overview
Corporate overview ASX:ACW Actinogen is an ASX-listed biotech company focused on innovative approaches to treating cognitive impairment associated with neurological and metabolic diseases Trading metrics Share price performance Price (A$) Volume (m) Share price (12 October 2020) A$0.028 No. of share
Slide 26: Board of Directors
Board of Directors Commercially experienced and globally recognised leadership team with decades of experience in drug development and biotech investment Dr. Geoff Dr. Bill Dr. George Mr. Malcolm Brooke Ketelbey Morstyn McComas Chairman CEO & MD Non-executive Non-executive director director 30+ ye
Slide 27: Advisory Boards
Advisory Boards World-leading, premier academics involved in the development of Xanamem Xanamem Clinical Advisory Board Scientific Advisory Board Positions Xanamem at the forefront Combining deep understanding of endocrinology, of drug development 11β-HSD1 and drug discovery Prof. Craig Ritchie Prof
Slide 28: IP protection
IP protection Actinogen maintains a broad composition of matter patent estate, with key patents granted in all major target markets, and new patent applications filed or in development Patent overview Actinogen’s patent portfolio covers a broad range of neurological and metabolic diseases includin
Slide 29: Appendix B: Other clinical development opportunities
Appendix B: Other clinical development opportunities
Slide 30: Cognitive impairment associated with schizophrenia
Cognitive impairment associated with schizophrenia Cognitive impairment can be a debilitating feature of schizophrenia, with no targeted treatments available representing a significant unmet medical need Schizophrenia is a complex and chronic mental health disorder that has Schizophenia increasing
Slide 31: Cognitive impairment associated with diabetes
Cognitive impairment associated with diabetes Diabetics are at increased risk of developing cognitive impairment and Alzheimer’s disease Elderly diabetics have double the risk of developing cognitive impairment and At-risk dementia over a non-diabetic population population Diabetics often presen
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