Actinogen Medical Limited · ASX:ACW
Actinogen Medical — Clinical Trials Science Forum (August 2023)
21 slides from Actinogen Medical's conference presentation, Aug 31, 2023
Slide 1: ASX Announcement: Maruff and Hilt fireside chat webinar
ASX ANNOUNCEMENT Professor Paul Maruff joins Actinogen CMO, Dr Dana Hilt, today in a ‘fireside chat’ to review progress in evaluation of cognition, Alzheimer’s disease and Xanamem’s® clinical data Prof Paul Maruff & Dr Dana Hilt neuroscience webinar: 11am today, 31 August 2023 Event registration: ht
Slide 2: About Actinogen Medical and clinical trials
Investors Dr. Steven Gourlay Michael Roberts CEO & Managing Director Investor Relations P: +61 2 8964 7401 M: +61 423 866 231 E. steven.gourlay@actinogen.com.au E. michael.roberts@actinogen.com.au Announcement authorised by the Board of Directors of Actinogen Medical About Actinogen Medical Actinoge
Slide 3: Disclaimer
Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical. Disclaimer This announcement and attachments may contain certain "forward-looking statements" that are not his
Slide 4: Xanamem: Potential for Benefit in a Number of CNS conditions
For personal use only Xanamem® : Potential for Benefit in a Number of CNS conditions Phase 2 studies to be conducted in MDD (Major depressive disorder) and mild/moderate AD Dana C Hilt MD, CMO Actinogen Medical ® Xanamem is a registered trademark of Actinogen Medical Limited
Slide 5: For personal use only
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 information neces
Slide 6: Introduction and welcome
For personal use only Introduction and welcome Dr Steven Gourlay Dr Dana Hilt MBBS FRACP PhD MBA MD Chief Executive Officer Chief Medical Officer ACW webinar 31 Aug 2023 3
Slide 7: Clinical Trials Science Forum
For personal use only Clinical Trials Science Forum 4
Slide 8: Agenda
Agenda For personal use only Michael Roberts Welcome Investor Relations Dr Steven Gourlay Introduction Chief Executive Officer Professor Paul Maruff Progress in evaluation of cognition, Alzheimer’s disease and Xanamem’s clinical data Prof. Neuroscience and Co-Founder, Cogstate Ltd Dr Dana Hilt Xanam
Slide 9: Fireside chat format discussion
For personal use only “Fireside chat” format discussion Professor Maruff & Dr Hilt MD ACW webinar 31 Aug 2023 6
Slide 10: Xanamem: Oral, low dose, once-a-day treatment with unique mechanism
Xanamem: Oral, low dose, once-a-day treatment with a unique (mainly) non-amyloid/tau mechanism For personal use only Only known brain penetrant 11β-HSD1 small molecule enzyme inhibitor Reduces cortisol in brain - modulating signalling pathways and potentially underlying disease processes1,2 11β-HSD1
Slide 11: Xanamem Clinical data
Xanamem Clinical data Two separate normal volunteer studies have shown procognitive effects of For personal use only Xanamem: Attention, working memory, and executive function Re-analysis of the Phase 2 XanADu AD study shows procognitive and potentially clinical benefit in high pTau subgroup of AD p
Slide 12: Xanamem gets into the brain and binds to its target
Xanamem gets into the brain and binds to its target at safe and well tolerated doses Previous molecules to this target have not achieved adequate brain concentrations as For personal use only they were poorly CNS penetrant PET data demonstrates that Baseline After Dose Xanamem extensively binds to t
Slide 13: Xanamem in normal volunteers: improves attention cognition domains
Xanamem in normal volunteers: Improves attention cognition domains in XanaHES* study by Week 4 For personal use only One Back Test (working memory) Identification Test (visual attention) Detection Test (psychomotor function) 0.02 0.1 0.055 0.01 0.08 0.035 0.06 Mean change from baseline 0 Improved pe
Slide 14: Xanamem confirms improved attention/working memory in second trial
Xanamem confirms improved attention/working memory by 4-6 weeks at lower doses in second trial Computerized Cogstate test battery positive results in cognitively normal older people For personal use only XanaMIA Phase 1b trial (n=107, Xanamem 10 mg & 5 mg) 0.5 ON-TREATMENT VISITS BETTER 0.4 Attentio
Slide 15: Xanamem prevents clinical decline in p-Tau181 elevated AD patients
Xanamem prevents clinical decline in p-Tau181 elevated AD patients: Positive clinical effects In trial participants with p-Tau181 > 6.74 pg/mL, Xanamem demonstrates disease For personal use only stabilization on CDR-SB Xanamem 10 mg Xanamem Placebo Placebo -1 -0.5 CDR-SB units Change from 0 Baseline
Slide 16: Newer anti-amyloid antibodies slow but not halt progression of AD
Newer anti-amyloid antibodies shown to slow but not halt progression of AD1 Ideally patients would not worsen on treatment For personal use only 0 -5 -10 Large area of unmet need -15 requires non- % worsening amyloid therapies CDR-SB2 over -20 18 months -25 -30 -35 lecanemab donanemab all donanemab
Slide 17: Xanamem moving to POC Phase studies: AD and Cognitive Impairment in Depression
For personal use only Xanamem moving to POC Phase 2 studies: AD and Cognitive Impairment in Depression Biomarker trial data validate & simulate the planned Phase 2b protocol in patients with mild to moderate AD and elevated blood pTau ACW webinar 31 Aug 2023 14
Slide 18: Xanamem Phase & program
Xanamem Phase 2 & 3 program Building on three independent Phase 1 and 2 studies showing safety and procognitive activity For personal use only Current Phase 1 & 2a, biomarker Safety, cognition activity demonstrated (n > 300 patients) Phase 2b Phase 2a Cognitive Impairment Alzheimer’s Disease (AD) in
Slide 19: Questions
For personal use only Questions ACW webinar 31 Aug 2023 16
Slide 20: Clinical Trials Science Forum
For personal use only Clinical Trials Science Forum 36
Slide 21: Thank you
For personal use only Thank you If you have any questions following the event please contact: Michael Roberts Investor Relations M. +61 423 866 231 E. michael.roberts@actinogen.com.au ACW webinar 31 Aug 2023 18
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