Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Corporate Update (June 2019)
33 slides from Actinogen Medical's corporate update, Jun 26, 2019
Slide 1: Xanamem Clinical Development and Investor Update
ASX ANNOUNCEMENT Xanamem Clinical Development and Investor Update Sydney, 26 June 2019. Actinogen Medical (ASX: ACW, ‘ACW’ or ‘the Company’) is pleased to provide an update on the progress the Company is making with the ongoing clinical development program for Xanamem™. This update should be read in
Slide 2: ASX announcement continued: studies, manufacturing, partnering
• The Company is pleased to confirm that initial results observed demonstrate that Xanamem inhibits the 11β-HSD1 enzyme in the brain (refer to slide 11 of the attached Investor Presentation). Target Occupancy: Homogenate Binding Studies • This suite of complex in-vitro studies is being conducted in
Slide 3: Updated Investor Presentation (attached)
Updated Investor Presentation (attached) • The latest investor presentation highlights progress achieved to date. • Particular emphasis is made to the impressive pharmacodynamic effects of Xanamem from the XanADu study (slide 9); the preliminary data from the Target Occupancy study (slides 10 and 11
Slide 4: About Xanamem, XanADu and XanaHES
brain affecting memory. The 11β-HSD1 enzyme is highly concentrated in the hippocampus and frontal cortex, the areas of the brain associated with cognitive impairment in neurological diseases, including Alzheimer’s disease, mood disorders and schizophrenia. About XanADu XanADu is a Phase II double-bl
Slide 5: Investor Presentation
Investor Presentation A novel approach to treating cognitive impairment and Alzheimer’s disease Dr. Bill Ketelbey: CEO & MD June 2019
Slide 6: Company Overview
Company Overview Actinogen is developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases, with an initial focus on Alzheimer‘s disease Xanamem - lead compound Cognitive impairment focus Clinical stage asset Potential value upside De-risked opportuni
Slide 7: Xanamem
Xanamem A novel drug designed to inhibit cortisol production in the brain, with the potential to treat cognitive impairment A novel, first in class, potent, orally bioavailable, brain-penetrant, 11β-HSD1 inhibitor Differentiated mechanism of action: inhibiting cortisol production in the brain Xa
Slide 8: Development Pipeline and Upcoming Catalysts
Development Pipeline and Upcoming Catalysts Significant upcoming milestones across first half 2019 Studies 1Q CY2019 2Q CY2019 3Q CY2019 4Q CY2019 Key Catalysts Completed study report Q3 CY2019 Future strategy for Xanamem Phase I Target Occupancy drug development will be Preliminary data received. i
Slide 9: Commercial Strategy
Commercial Strategy Xanamem development and commercial opportunities informed by totality of output from current studies Xanamem has demonstrated to be a safe, brain penetrant, orally available, selective 11β –HSD1 inhibitor with significant pharmacodynamic effects on cortisol-related hormones Near-
Slide 10: Xanamem Drug Development Pipeline
Xanamem Drug Development Pipeline XanADu Phase II clinical trial design, endpoints and initial results Clinical Target Occupancy and Homogenate Binding Studies XanaHES Phase I higher dose safety study Pre-Clinical long-term in vivo safety and toxicology studies
Slide 11: XanADu is one part of a larger development program
XanADu is one part of a larger development program The ongoing comprehensive review of the data and results from XanADu and the additional studies will inform the optimal clinical development path Multiple endpoints and sub analyses will allow Assess safety and tolerability of higher doses, with ins
Slide 12: XanADu Results
XanADu Results Initial results announced 7th May 2019 Pharmacologically active drug - potent pharmacodynamic Next steps: modulation of cortisol-related hormones Strong safety profile 2 Current analyses together with ongoing Xanamem studies will inform the future development strategy in Alzheimer’s d
Slide 13: XanADu Study – Pharmacodynamic Results
XanADu Study – Pharmacodynamic Results Xanamem 10mg once-daily resulted in early and significant pharmacodynamic modulation of cortisol-related hormones throughout the 12-week study ACTH: 12 weeks treatment Androstenedione: 12 weeks treatment DHEA-S: 12 weeks treatment LS Mean Changes from baseline
Slide 14: Xanamem – Phase I Target Occupancy Study & Homogenate Binding Studies
Xanamem – Phase I Target Occupancy Study & Homogenate Binding Studies To assist with confirming and optimising Xanamem dosing To accurately demonstrate the effects different doses of Xanamem have on inhibiting the Aim 11β-HSD1 enzyme in the human brain. Phase I Target Occupancy studies In vitro Homo
Slide 15: Phase I Target Occupancy Study: Preliminary Results
Phase I Target Occupancy Study: Preliminary Results Phase I target occupancy study demonstrates that 10mg Xanamem dosed for seven days significantly occupies neuronal 11β-HSD1 throughout the brain Baseline Post Xanamem 51% - 85% occupancy, dependent upon brain region and study subject • Further stud
Slide 16: Xanamem in Healthy Elderly Volunteers
Xanamem in Healthy Elderly Volunteers Phase I double-blind, randomised, placebo-controlled, dose escalation study to assess the safety and efficacy of Xanamem in healthy elderly volunteers Expand the Xanamem safety dataset - evaluate potential for higher drug doses to be Aim used in future clinical
Slide 17: Xanamem – Long-Term Safety and Toxicology Studies
Xanamem – Long-Term Safety and Toxicology Studies Evaluate safety and toxicology in rodent (six months) and dog (nine months) studies Aim in preparation for Phase III development Studies required by all regulators - FDA Will allow future clinical studies beyond 12 weeks Studies ongoing Key stu
Slide 18: Totality of data will inform future clinical development
Totality of data from XanADu and ongoing Xanamem studies will inform future clinical development 1 Data from XanADu and nine additional studies will read out over the coming months XanADu - Significant pharmacodynamic effects indicating potent target engagement XanADu - Safety clearly established wi
Slide 19: New Strategic Indications
New Strategic Indications Mood disorders, including bipolar disorder Schizophrenia
Slide 20: Assessment of New Target Indications
Assessment of New Target Indications Following extensive scientific, clinical, and commercial review, cognitive impairment in mood disorders and schizophrenia selected as the next indications for development and commercialisation of Xanamem 12 indications assessed Scientific Significant clinical i
Slide 21: Cortisol in Mood Disorders & Schizophrenia
Cortisol in Mood Disorders & Schizophrenia Overview of Clinical Rationale: Cognitive impairment can be a debilitating feature of mood disorders and schizophrenia; both diseases exhibit raised cortisol levels Hypothalamic–pituitary–adrenal (HPA) axis dysfunction has been well- Cognitive Psychiatric
Slide 22: Raised Cortisol & Cognitive Decline in Mood & Psychotic Disorders
Raised Cortisol & Cognitive Decline in Mood & Psychotic Disorders The link between raised cortisol, decreased hippocampal volume, and cognitive dysfunction in mood disorders Post-mortem brain study: Elevated mRNA levels of steroid-producing enzymes, including 11β-HSD1, in two brain regions associa
Slide 23: Significant Medical & Commercial Opportunities
Significant Medical & Commercial Opportunities Large patient populations and economic costs suggest a high unmet need with significant market opportunity for Xanamem to be used in combination with current therapies in order to address cognitive decline Depression Bipolar disorder Schizophrenia Preva
Slide 24: Competitive Landscape in Mood Disorders and Schizophrenia
Competitive Landscape in Mood Disorders and Schizophrenia Current cognitive enhancers pipeline is limited, with only one approved antidepressant treatment which may improve cognitive improvement, resulting in a significant opportunity for Xanamem Depression1 Bipolar disorder Schizophrenia One FDA
Slide 25: Summary
Summary
Slide 26: Summary
Summary Actinogen is developing innovative treatments for cognitive impairment associated with neurological and metabolic diseases with an initial focus on Alzheimer‘s disease Xanamem - lead compound Differentiated with a novel mechanism of action First-in-class, brain penetrant, orally active, smal
Slide 27: Appendix: New Indications – Disease Background
Appendix: New Indications – Disease Background
Slide 28: Cognitive Impairment in Mood Disorders & Schizophrenia
Cognitive Impairment in Mood Disorders & Schizophrenia Cognitive impairment can be a debilitating feature of mood disorders and schizophrenia – conditions exhibiting raised cortisol levels High cortisol levels are found in severe mood Xanamem’s differentiated mechanism of action may improve disord
Slide 29: Cognitive Impairment Associated with Depression
Cognitive Impairment Associated with Depression Overview of Clinical Rationale & Unmet Need Cognitive deficits in depression are clinically significant and include reduced executive function1, attention, memory & cognitive speed2 Cognitive decline can lead to poor functional outcome & potentiall
Slide 30: Cognitive Impairment Associated with Schizophrenia (CIAS)
Cognitive Impairment Associated with Schizophrenia (CIAS) Overview of Clinical Rationale & Unmet Need Schizophrenia: complex disorder with array of symptoms – positive, negative & cognitive High prevalence of cognitive decline (30 – 75%) in schizophrenic patients1 CIAS usually precedes the ons
Slide 31: Cognitive Impairment in Bipolar Disorder (CIBD)
Cognitive Impairment in Bipolar Disorder (CIBD) Overview of Clinical Rationale & Unmet Need General lack of understanding of the severity of CIBD Over half (40-60%) of patients with bipolar disorder have clinically significant cognitive impairment Impairment is present in manic, depressed, and
Slide 32: Disclaimer
Disclaimer
Slide 33: 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