Alterity Therapeutics Ltd. · ASX:ATH
Alterity Therapeutics — Prana Biotechnology — Shareholder Meeting (November 2015)
25 slides from Alterity Therapeutics's shareholder meeting presentation, Nov 13, 2015
Slide 1: Annual General Meeting
Annual General Meeting 13 November 2015
Slide 2: Safe Harbour
Safe Harbour This presentation may contain some statements that may be considered “Forward-Looking Statements”, within the meaning of the US Securities Laws. Thus, any forward-looking statement relating to financial projections or other statements relating to the Company’s plans, objectives, expecta
Slide 3: Prana Portfolio
Prana Portfolio PBT2: PBT2: Huntington disease Alzheimer’s disease PBT434: MPAC library Parkinsonian diseases
Slide 4: PBT2 – Huntington Disease Program
PBT2 – Huntington Disease Program • Reach2HD Phase II trial met its primary end points • Results published in Lancet Neurology, Nov 2014 • Further drug exposure studies show a trend to increased improvement in the cognitive tests with increasing drug exposure • consistent with the findings of the Re
Slide 5: PBT2 – Alzheimer's Disease
PBT2 – Alzheimer’s Disease Phase 2 ‘EURO’ clinical trial • Demonstrated significant improvement in Executive Function • Results published Lancet Neurology (Lannfelt et al 2008, 2009) Support for the PBT2 Mechanism Of Action grows • Targeting both abeta and tau, reducing abeta oligomers and phosphory
Slide 6: PBT2 – IMAGINE Open Label extension
PBT2 – IMAGINE Open Label extension • 52 week Clinician-initiated Open Label Extension Trial expanded strong safety package • 82% of originally included IMAGINE trial participants completed the full 24 months of treatment (12 months placebo-controlled phase + 12 months extension) • 12 month “IMAGINE
Slide 7: PBT434 – Parkinsonian conditions
PBT434 – Parkinsonian conditions • Over the past 2 years PBT434 has been profiled in mouse models of orphan and non-orphan Parkinsonian conditions including: • Parkinson’s disease • Multiple System Atrophy • Tauopathies (e.g. Corticobasal Degeneration, Progressive Supranuclear Palsy) • Comprehensive
Slide 8: MPAC Library
MPAC Library • 2000+ potential compounds • PBT519 Brain Cancer (GBM) • Reduced tumor growth in both mouse and human GBM cell lines • Spared non cancerous astrocytes • Effect additive with Temozolamide (SOC) • Two tiered research program: • Undertake new MPAC design and synthesis; and • Translational
Slide 9: Strong safety package
Strong safety package • PBT2 has completed four Phase I trials and four Phase II trials with good recruitment, high retention and completion rates • Each was reviewed by the independent Data Safety Monitoring Board. No safety concerns identified or changes to the protocols • Based on this strong saf
Slide 10: Partial Clinical Hold (PCH)
Partial Clinical Hold (PCH) What does it mean? • FDA placed PBT2 on PCH in Feb 2015 based on particular non-clinical neurotoxicology findings in dog studies • Dose of PBT2 has been limited to an amount that is not considered clinically relevant and therefore has resulted in delays to the commencemen
Slide 11: Orphan drug designation granted
Orphan drug designation granted • PBT2 has been granted Orphan Drug designation for Huntington’s disease: • European Commission: June 2015 • US FDA: September 2014 • To achieve Orphan designation, the drug must have the potential to offer plausible benefits to patients for indications affecting a sm
Slide 12: Conclusion
Conclusion • The need for treatments for neurodegenerative disease remains critical to patients, families and the healthcare economy • Based on the promising safety and efficacy data package, Prana remains committed to the further development of PBT2, PBT434 and new clinical leads from our MPAC libr
Slide 13: Ira Shoulson MD
Ira Shoulson MD Professor of Neurology, Pharmacology & Human Science Director, Program in Regulatory Science and Medicine (PRSM) http://regulatoryscience.georgetown.edu Georgetown University, Washington DC USA Non-Executive Director, Prana Biotechnology Melbourne VIC Australia
Slide 14: Cognitive Decline and Dementia
Cognitive Decline and Dementia Progressive intellectual decline in adults resulting in serious and seemingly irreversible disability Many types and causes • Degenerative diseases wherein brain nerve cells (neurons) loose their vitality and capacity to function • Vascular diseases causing repeated in
Slide 15: Degenerative Diseases Causing Dementia and Worldwide Prevalence
Degenerative Diseases Causing Dementia and Worldwide Prevalence (2010, 2030, 2050) • Alzheimer (36 million, 66 million, 115 million) • Parkinson (5 million, 9 million, 15 million) • Huntington (100,000) • Others
Slide 16: Huntington Disease
Huntington Disease Movement Disorders Cognitive Impairment Behavioral Disorders Clinical Expanded CAGn Selective Neuronal Consequences on Chromosome 4 Degeneration Genetic Brain Phenotype Clinical Etiology & Pathogenesis Phenotype
Slide 17: Huntington Disease
Huntington Disease • Unmet treatments needs for HD • Status of R&D for HD • Why PBT2 is worth pursuing
Slide 18: FDA Huntington Disease Public Meeting on Patient Focused Drug Development
FDA Huntington Disease Public Meeting on Patient Focused Drug Development Sept 22, 2015 Important and recurrent themes expressed by patients and families • Cognitive impairment is the most important problem and unmet need in HD, cited by 66% of patients in the room and 80% patients on the webcast. •
Slide 19: HD RCTs Underway or Completed
HD RCTs Underway or Completed • 25 HD RCTs in various phases of activity per HD Insights, June 2015 • per www.Clinicaltrials.gov 19 placebo-controlled RCTs initiated, active or completed between January 2005 and June 2015 • Collectively involved 3152 research participants • About 40% these RCTs have
Slide 20: Clinical Trials Up
date Clinical Trials Up SPONSOR STUDY STUDY PHASE PRINCIPAL DESIGN STATUS NAME/ AGENT INVESTIGATOR, IDENTIFIER CONTACT Randomized double-blind study testing the Enrollment Charité ETON-Study Epigallocatechin m Josef Priller, MD efficacy and tolerability of (2)-epigallocatechin-3- Lyear 4 total - com
Slide 21: Trail Making Test Part B - Sample
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Slide 22: Trail Making Test Part B
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Slide 23: High-Dose PBT2 Improves Trails Making Test B Cognition
High-Dose PBT2 in Alzheimer’s (EURO) and Early Huntington Disease (Reach2HD) Significantly Improves Trails Making Test B Cognition EURO Trail Making Test Part B REACH2HD Trail Making Test Part B LS Mean (SE) Change from Baseline LS Mean (SE) Change from Baseline 25 25 15 15 5 5 Time (seconds) Time (
Slide 24: Letter to Friends, November 2015
12 November, 2015 Dear Friends, I am writing this letter, first, to express my appreciation for your support of Prana Biotechnology and, more generally, drug development aimed at preventing and treating this terrible disease called Alzheimer’s disease (AD). Second, I would like to take the opportuni
Slide 25: Letter continued: Alzheimer's-in-a-Dish
role in controlling neuroinflammation in AD. These are now serving as drug targets for regulating neuroinflammation in AD. This is particularly important in patients with mid-late stage AD. The newest combined genetic, imaging, biomarker, and Alzheimer’s-in-a-Dish data now collectively illustrate a
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