Alterity Therapeutics Ltd. · ASX:ATH
Alterity Therapeutics — Prana Biotechnology — Shareholder Meeting (November 2015)
23 slides from Alterity Therapeutics's shareholder meeting presentation, Nov 13, 2015
Slide 1: Annual General Meeting November 2015
Annual General Meeting 13 November 2015
Slide 2: 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, expectatio
Slide 3: Prana Portfolio
Prana Portfolio PBT2: Huntington disease PBT2: Alzheimer’s disease PBT434: Parkinsonian diseases MPAC library
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 R
Slide 5: PBT2 – Alzheimer's Disease
PBT2 – Alzheimer’s Disease Phase 2 ‘EURO’ clinical trial • D emonstrated 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 phosphor
Slide 6: 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’ study did not significantly r
Slide 7: 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 IND - enabling non clinical p
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 commencem
Slide 11: 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 small percentage of the populatio
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
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 injury to nerve cells • Genetic •
Slide 15: Degenerative Diseases Causing Dementia and Worldwide Prevalence
• Alzheimer ( 36 million, 66 million, 115 million ) • Parkinson ( 5 million, 9 million, 15 million ) • Huntington (100,000) • Others Degenerative Diseases Causing Dementia and Worldwide Prevalence ( 2010 , 2030 , 2050 )
Slide 16: Huntington Disease
Movement Disorders Cognitive Impairment Behavioral Disorders Selective Neuronal Degeneration Clinical Consequences Expanded CAG n on Chromosome 4 Genetic Etiology Brain Phenotype & Pathogenesis Clinical Phenotype Huntington Disease
Slide 17: Huntington Disease
• Unmet treatments needs for HD • Status of R&D for HD • Why PBT2 is worth pursuing Huntington Disease
Slide 18: 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. • Examples of cognitive impairment mentioned: inability to concentrate and complete tasks, problems balancing a checkbook and making change, following sequ
Slide 19: 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 not yet reported results in
Slide 20: Clinical Trials Update
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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 Significantly 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 -55 -45 -35 -25 -15 -5 5 15 25 BL Week 12 Week 26 Time (seconds) REACH2HD Trail Making Test Part B LS Mean (SE) Change from Baseline PLACEBO (n=35) PBT2 100mg (n=38) P
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