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  • Orasi develops products to diagnose and monitor neurological diseases. Technology licensed from University of Minnesota, and based on 5 years of R&D 2. Orasi develops products for the clinical and pharmaceutical market. Clinical = GP’s and Neurologists who will use this product to diagnose Alzheimer’s patients Pharmaceutical = Two product offerings. 1) Patient selection and 2) Measuring the effect of new drugs LINK: Let’s look at these two markets more closely and why there is a need for a better diagnostic technology
  • Orasi develops products to diagnose and monitor neurological diseases. Technology licensed from University of Minnesota, and based on 5 years of R&D 2. Orasi develops products for the clinical and pharmaceutical market. Clinical = GP’s and Neurologists who will use this product to diagnose Alzheimer’s patients Pharmaceutical = Two product offerings. 1) Patient selection and 2) Measuring the effect of new drugs LINK: Let’s look at these two markets more closely and why there is a need for a better diagnostic technology
  • Patient friendly, can be accompanied, no need to undress, stare at a dot for 1 minute, QUICK – 60 seconds of data Data collected across 248 sensors, Measures the tiny magnetic field generated by the electrical activity from firing neurons Sampled at very high frequency 1 Khz Data sent over the web to Orasi central data processing facility (automated) Statistical model of brain activity created for each subject, compare each subject to disease template. Brain activity is based on the amount of synchronous activity between neuronal populations Sent to physician to aid in diagnosis, e.g. AD or Not AD LINK: Mark will explain more about MEG
  • Why can’t pharmaceutical companies accurately determine which drugs will benefit patients early in the process?
  • Why can’t pharmaceutical companies accurately determine which drugs will benefit patients early in the process?
  • Post-hoc analysis 7 AD subjects not taking AD medications 15 AD subjects on a stable dose of donepezil Identified SNI pattern that differed significantly between groups Excellent results, superior to the current standard of care. As good or better than other technologies currently being researched.
  • 155 patient study Multicenter study to identify patterns associated with Dementia of Alzheimer’s Type (DSM-IVTR) Previously diagnosed dementia patients and matched healthy controls Excellent results, superior to the current standard of care. As good or better than other technologies currently being researched.
  • Excellent results, superior to the current standard of care. As good or better than other technologies currently being researched.
  • Orasi develops products to diagnose and monitor neurological diseases. Technology licensed from University of Minnesota, and based on 5 years of R&D 2. Orasi develops products for the clinical and pharmaceutical market. Clinical = GP’s and Neurologists who will use this product to diagnose Alzheimer’s patients Pharmaceutical = Two product offerings. 1) Patient selection and 2) Measuring the effect of new drugs LINK: Let’s look at these two markets more closely and why there is a need for a better diagnostic technology
  • Use this slide to close each presentation.
  • Transcript

    • 1. Orasi Medical
      • Shawn Lyndon, CEO
    • 2. “… predicting clinical efficacy (drug effect) is one of the greatest bottlenecks in drug research and development” D. O’Connell, A.Hopkins and D. Roblin, International Joural of Pharmaceutical Medicine, 2007:21(5): 339-345, “Is it time to revist the current R&D model?”
    • 3. Orasi Overview
      • 2007 University of Minnesota start-up
      • Diagnoses neurological diseases and measures the effect of neurological treatments
          • Initial targets: Alzheimer’s disease, multiple sclerosis, schizophrenia
      • $6M in funding to date
      • Primary Market: CNS Pharmaceutical Companies
      Orasi analyzes brain function to diagnose neurological diseases and measure treatment effect using a software-as-a-service model.
    • 4. How does the SNI test work? 2. Brain activity measured across sensors 1. Non-invasive test (MEG/EEG) 3. Raw data exported from MEG/EEG machine 4. Orasi data center (Secure web data transmission/storage) 5. Analysis of brain function using Orasi SNI™ 6. Results available online for diagnosis and/or measuring treatment effect
    • 5. Drug Development - Landscape Confidential - do not reproduce or distribute.
    • 6. Challenges of drug development
      • 95-97% of all neurological drugs fail to reach the market
          • #1 reason for failure is due to insufficient clinical efficacy 1
      • Drug to market cost = $1B on average
          • Increased by 50% between 2002 and 2007
      • Time to market = 12-13 years on average
      Pharmaceutical companies lack the tools to accurately measure the effect of new and novel CNS drugs.
      • Hurko and Ryan October 2005, Vol. 2, 671-682 “The American Society for Experimental NeuroTherapeutics, Inc”
    • 7. Pharmaceutical (CNS) needs for improving clinical efficacy
      • Confirm the drug reaches the brain
      • Select the correct dose
      • Select the right patients for the clinical trial
            • Identify patients that will respond to treatment
            • Select patients early in the disease (asymptomatic)
      • Measure chronic (weeks and months) treatment effect and disease progression
            • “Go”/”No-go” decision for continuing drug development
            • Secondary outcome measure to support clinical efficacy and regulatory clearance
    • 8. Orasi’s SNI Test™ confirms the drug reaches the brain A. Statistical probability B. Magnitude of difference A. Statistical probability B. Magnitude of difference A. Statistical probability B. Magnitude of difference A. Statistical probability B. Magnitude of difference 100 35 Case Study: Evaluating treatment effect of Donepezil (Aricept®) in Alzheimer’s subjects (n=23) Aricept® (Donepezil) Signature Alzheimer’s Disease Signature
    • 9. Orasi’s SNI Test™ measures drug effect Case Study: Evaluating treatment effect (withdrawing alcohol) in single alcoholic male over 15 day period Day 1 Day 3 Day 5 Day 6 Day 7 Day 15
    • 10. Disease-specific signatures for patient selection Alzheimer’s Disease (n=155) Schizophrenia (n=18) Multiple Sclerosis (n=224) Normal/Healthy (n=74)
    • 11. Orasi’s SNI Test separates Alzheimer’s and healthy controls Classification accuracy: Specificity = 90%, Sensitivity = 94%, n=155 Age Sex (M/F) MMSE ADAS (SOB) CDR AD (DAT) 77 ± 7 50/34 20 ± 7 24 ± 1.3 1.2 ± 0.1 Control 66 ± 17 30/41 29 ± 1 ND ND
    • 12. Orasi’s SNI™ Test correlates with disease progression (Alzheimer’s) Confidential - do not reproduce or distribute. 0.9 9.6 MMSE range: 26-30 26-30 20-25 < 20 Group size: 71 16 36 30 Correlation with MMSE SNI Severity Index
    • 13. “ The FDA estimates that just a 10% improvement in the ability to predict drug failures before clinical trials could save US$100 million in development costs per drug” FDA 2004, “Innovation or stagnation? Challenge and opportunity on the critical path to new medical products”
    • 14.  

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