Actinogen Medical Limited · ASX:ACW
Actinogen Medical — BIO Digital 2020
25 slides from Actinogen Medical's conference presentation, June 2020
Slide 1: BIO DIGITAL 2020
BIO DIGITAL 2020 Dr. Bill Ketelbey: CEO & MD June 2020 Developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases due to raised cortisol, including Alzheimer’s disease
Slide 2: Xanamem™ – lead compound
Xanamem™ – lead compound A novel Mechanism of Action (MoA) designed to inhibit cortisol production in the brain (through 11β-HSD1 inhibition), with proof of concept in animals and in humans, and a strong safety profile Novel MoA (cortisol inhibition) PoC demonstrated in animal trials PoC demonstrate
Slide 3: Highlights: Demonstration of Xanamem's promising efficacy and safety
Highlights: Demonstration of Xanamem’s promising efficacy and safety A significantly enhanced and growing dataset Target Occupancy Comprehensive & Homogenate Data Analysis Binding studies Efficacy shown in Phase 1 Phase 2 clinical trial in mild QSP1 and PK/PD2 modelling Phase 1 Target Occupancy, cli
Slide 4: Significant cognitive efficacy signal achieved
Significant cognitive efficacy signal achieved Breakthrough XanaHES results demonstrate robust statistically significant cognitive efficacy improvement in multiple cognition domains – based on Cogstate Cognitive Test Battery Working memory (One Back Test) Visual attention (Identification Test) Psych
Slide 5: Significant cognitive efficacy signal achieved
Significant cognitive efficacy signal achieved Cogstate Cognitive Test Battery evaluated six domains. Statistically significant cognitive improvement in three domains with significant effect size demonstrated. Rapid and sustained response achieved. Cognitive Evaluation (Test) p value Treatment Effec
Slide 6: 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 occupies the neuronal 11β-HSD1 enzyme throughout the brain (31 of 36 patients completed) 50% to 85% occupancy, dependent upon brain region, dosag
Slide 7: Key outcomes from Xanamem studies
Key outcomes from Xanamem studies Xanamem dose Cognitive Breakthrough results demonstrate a statistically significant clinical effect 20mg Efficacy in improving cognition in healthy elderly patients Target Confirms Xanamem works as designed to penetrate the brain in 5mg - 30mg Occupancy concentratio
Slide 8: Detailed data analysis in final stages
Detailed data analysis in final stages Quantitative Systems Pharmacology modelling and analysis underway Genetic Human information pathology, clinical data Human physiology dyi = f1(x1 y1 . y1....y2) dx ......... dyu dx = fn(xn y1 . y1...yn) In vivo data Therapeutic predictions Analysis of entire da
Slide 9: Strategic direction and next steps
Strategic direction and next steps Updated clinical development plan incorporating new Xanamem data supporting clinical development opportunities across multiple indications Enhanced clinical development strategy Next steps (in progress) (near future) Comprehensive review of all Xanamem data, new
Slide 10: Next series of Xanamem studies
Next series of Xanamem studies Actinogen leveraging Xanamem development across multiple target indications A pipeline of potential opportunities Optimising study parameters Alzheimer’s Disease (MCI due to AD) Dosing Treatment Dose ? Regimen Duration Schizophrenia1 Diabetes2 Phase II studies for cogn
Slide 11: Mild Cognitive Impairment (MCI) due to Alzheimer's disease
Mild Cognitive Impairment (MCI) due to Alzheimer’s disease Everyone experiences slight cognitive changes during aging, with the progression to dementia becoming slowly apparent in everyday functionality and worsening over time as cognitive domains are impaired Normal Aging Preclinical Mild Silent ph
Slide 12: Alzheimer's disease – Mild Cognitive Impairment due to AD
Alzheimer’s disease – Mild Cognitive Impairment due to AD Actinogen plans to target patients with Mild Cognitive Impairment due to AD (an early stage of the AD spectrum) as part of the next phase of studies, linking the XanaHES results with Alzheimer’s disease Healthy elderly Mild Moderate Severe Mi
Slide 13: MCI due to Alzheimer's Disease
MCI due to Alzheimer’s Disease A large patient population significantly at risk of developing AD, with no approved therapy • Patients with AD pathological changes, subtle or more apparent MCI in AD detectable abnormalities on sensitive neuropsychological measures, and a mild but detectable functiona
Slide 14: Cognitive impairment due to diabetes
Cognitive impairment due to diabetes Diabetics are at increased risk of developing cognitive impairment and AD • Elderly diabetics have double the risk of developing cognitive At-risk impairment and dementia over a non-diabetic population population • Diabetics often present with chronically raised
Slide 15: Diversified Opportunity: Cognitive impairment due to schizophrenia
Diversified Opportunity: Cognitive impairment due to schizophrenia Significant unmet medical need with substantial pharma industry interest • Cognitive impairment is one of the most debilitating negative symptoms in schizophrenia, affecting ~75% of patients1 Cognitive • Associated with poor treatmen
Slide 16: Investment summary
Investment summary Actinogen is developing Xanamem for cognitive impairment associated with raised cortisol in neurological and metabolic diseases, with a primary focus on MCI due to Alzheimer’s disease Xanamem – a differentiated compound (efficacious, oral, brain penetrant, selective 11β-HSD1 inh
Slide 17: 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 18: APPENDIX: Background information
APPENDIX: Background information
Slide 19: 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 Share price performance Board of Directors Price (A$) Volume (m) 0.080 480 Dr. Geoff Brooke Dr. Bill Ketelbey Ch
Slide 20: Advisory Boards
Advisory Boards World-leading, premier academics involved in the development of Xanamem as a novel treatment for Alzheimer’s disease Clinical Advisory Board (Alzheimer’s disease) Scientific Advisory Board Positions Xanamem at the forefront of Combining deep understanding of endocrinology, Alzheimer’
Slide 21: IP protection
IP protection Actinogen maintains a broad composition of matter patent estate, with key patents granted in all major target markets Patent overview Actinogen’s patent portfolio covers a broad range of neurological and metabolic diseases including Alzheimer’s disease Xanamem patents granted in ke
Slide 22: Xanamem
Xanamem A novel drug designed to inhibit cortisol production in the brain, with the potential to treat cognitive impairment across multiple diseases Well researched Differentiated mechanism of action: >15 years of R&D completed Highly selective 11βHSD1 inhibitor, reducing excess cortisol production
Slide 23: Alzheimer's strategic focus underpinned by medical research
Alzheimer‘s strategic focus underpinned by medical research A growing body of medical literature supports the association between cortisol and Alzheimer‘s disease Raised cortisol associated with Alzheimer’s disease1 Supported by growing body of medical literature 0.8 Many studies support the associa
Slide 24: Market dynamics of Alzheimer's disease
Market dynamics of Alzheimer’s disease MCI due to AD and Mild AD present a compelling commercial opportunity for Actinogen to target Substantial target market with significant upside1 Underpinned by favourable market dynamics Subjective Targeting large addressable markets (US, EU5, JP) Cognitively
Slide 25: Significant upside potential, underpinned by recent deals
Significant upside potential, underpinned by recent deals Global Big Pharma demonstrating strong M&A interest in acquiring or partnering with companies and licensing novel mechanism of action assets with Alzheimer’s disease as the lead/key indication 3.5 2.4 3.3 1.8 Deal value (US$bn) 1.2 1.1 Upfron