Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Annual National Dementia Conference 2023, Cognitive Decline Emerging Treatments & Trends F
21 slides from Actinogen Medical's conference presentation, Jun 21, 2023
Slide 1: ASX Announcement: Actinogen CEO presents at National Dementia Conference
ASX ANNOUNCEMENT Actinogen CEO presents on emerging oral Alzheimer’s Disease therapies at the National Dementia Conference, Melbourne Sydney, 21 June 2023. Actinogen Medical ASX: ACW (“ACW” or “the Company”) is pleased to announce that its Chief Executive Officer and Managing Director, Dr Steven Gou
Slide 2: About Actinogen Medical and Xanamem
About Actinogen Medical Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affectin
Slide 3: Novel oral therapeutics in development for Alzheimer's Disease
For personal use only Novel oral therapeutics in development for Alzheimer’s Disease There is reason to believe that one or more novel, oral medications will emerge soon Dr Steven G Gourlay MBBS PhD, CEO & MD Actinogen Medical Cognitive Decline Emerging Treatments & Trends Forum, Melbourne June 21,
Slide 4: 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 For personal use only does not contain all inform
Slide 5: Defining the biology of Alzheimer's is like Michelangelo bringing out a human form
For personal use only Defining the biology of Alzheimer’s is a bit like Michelangelo bringing out a human form from stone Cognitive Decline Emerging Treatments & Trends Forum Melbourne June 21 2023 3
Slide 6: New anti-amyloid antibodies slow but do not halt AD progression
New anti-amyloid antibodies slow but do not halt AD progression For personal use only Area of unmet need for newer CDR-SB and novel non-amyloid units Lecanemab* therapies ~1.2 points Area of treatment effect ~0.45 points placebo Drugs targeting non-amyloid mechanisms are needed Anti-amyloid therapie
Slide 7: Most promising oral medication programs
Of the hundreds of candidates, what are some of the most promising oral medication programs? For personal use only Promising cognitive enhancers of any mechanism Promising disease- modifiers with non- amyloid mechanisms Cognitive Decline Emerging Treatments & Trends Forum Melbourne June 21 2023 5 Cu
Slide 8: Neuroinflammation, abnormal cell signaling, and insulin resistance
Neuroinflammation, abnormal cell signaling, and insulin resistance Amyloid and tau deposition may be secondary to these other processes For personal use only Amyloid plaques insulin resist- ance Inflamm -ation cortisol Tau tangles • Memory impairment • Difficulty solving problems • Difficulty functi
Slide 9: Few novel oral cognitive enhancers with evidence of cognitive benefit
There are relatively few novel oral cognitive enhancers with evidence of cognitive benefit Any mechanism For personal use only Non-prescription • Caffeine & nicotine- have brief effects Prescription • Acetylcholinesterase prescription drugs like donepezil (Aricept and others), rivastigmine, galantam
Slide 10: Potential in the non-amyloid field for oral disease-modifiers
There is some potential in the non-amyloid field for oral disease-modifiers Where there is some credible clinical data For personal use only Non-prescription • None although curcumin has been used in South Asian medicine Prescription • GV-971/oligomannate (China only), mechanism certain In Phase 3 c
Slide 11: Amyloid-mechanism oral disease-modifiers with credible cognitive data are few
Amyloid-mechanism oral disease-modifiers with credible cognitive data are few With pro-cognitive data in a randomized trial For personal use only Non-prescription • None Prescription • None In Phase 3 clinical trials • Simufilam (Improved cognition and biomarkers, one 28-day trial) In Phase 2 clinic
Slide 12: Xanamem: oral, low-dose, once-a-day treatment with unique mechanism
Xanamem: oral, low-dose, once-a-day treatment with a unique, non-amyloid/tau mechanism Rodent experimental studies & clinical trials validate cortisol target for treatment of AD 1-4 For personal use only Brain penetrant 11β-HSD1 small molecule enzyme inhibitor discovered at the University of Edinbur
Slide 13: Studies support association between elevated cortisol and AD
Many studies support the association between elevated cortisol and AD development and progression1-9 ▪ Higher cortisol levels in human aging are associated with For personal use only hippocampal atrophy1,2 ▪ Chronic corticosteroid medication is associated with hippocampal and amygdalar atrophy and c
Slide 14: PET data shows full target engagement in the brain at low doses
PET data shows full target engagement in the brain at low doses Previous enzyme inhibitors1 have not achieved adequate brain concentrations For personal use only Baseline After 7 days of daily dosing PET data2 demonstrates that Xanamem extensively binds to the 11β-HSD1 enzyme 5 mg Xanamem 10 mg Xana
Slide 15: Second trial confirms improved attention/working memory at lower doses
Second trial confirms improved attention/working memory at 4-6 weeks using lower doses of 5 – 10 mg Computerized cognitive testing in cognitively normal older people, 5, 10 mg daily vs. placebo For personal use only XanaMIA Phase 1b trial (n=107, Xanamem 10 mg & 5 mg combined) 0.5 ON-TREATMENT VISIT
Slide 16: Xanamem slows the rate of CDR-SB decline in mild AD
Xanamem slows the rate of CDR-SB (functional) decline in mild AD* Patients with elevated plasma pTau181 indicating progressive, amyloid- positive disease (n=34) For personal use only Xanamem Placebo -1 -0.5 CDR-SB units Change from 0 0 Baseline (SE) 0.36 * * Difference vs. placebo 0.5 • Mean 0.6 uni
Slide 17: Cognitive composite scores suggest potential clinical benefit across sub-types
Cognitive composite scores suggest potential clinical benefit across dementia patient sub-types* Positive trends in both high and low plasma pTau biomarker groups For personal use only Higher pTau biomarker (n=34) Lower pTau biomarker (n=34) 0.3 0.3 Composite Units (SE*) Composite Units (SE) 0.2 0.2
Slide 18: Timetable for trial results for oral AD therapies
Timetable for trial results for oral AD therapies Year Drug or company Target Steve’s probability For personal use only of success 2023 deferiprone Iron Low TauRx Tau* Low NE3107 ERK1/2 Low simufilam Filamen A* Low-Medium 2023 varoglutamstat pglu-Aβ/QC* Medium CT1812 Sigma-2* Low 2024 Valiltramprosa
Slide 19: Oral medication AD trials are recruiting in Australia
Oral medication AD trials are recruiting in Australia Phase 3 For personal use only • Statin drugs (STAREE trial) • Semaglutide EVOKE (GLP-1 antagonist, diabetes and weight loss treatment) • Simufilam (Filamen A) Phase 2 • MK-1942 (unknown mechanism) • LY3372689 (preventing tau tangle formation) • P
Slide 20: Contact Actinogen
Contact Actinogen How to access our Xanamem phase 2 trial in Alzheimer’s disease For personal use only Subscribe To receive information about or: https://actinogen.com.au/clinical- our clinical trials: Subscribe Contact Us development-pipeline/#patient-portal Web: actinogen.com.au Phone: +61 2 8964
Slide 21: The answers to Alzheimer's Disease are emerging
The answers to For personal use only Alzheimer’s Disease are emerging…. clinicaltrials.gov anzctr.org.au actinogen.com.au Cognitive Decline Emerging Treatments & Trends Forum Melbourne June 21 2023 19