Transcript SHERMAN BIOTECH

SHERMAN BIOTECH
SHERMAN BIOTECH
• Drug Development for Anxiety in Fragile X and Autism
• Diagnostic Test Development for Fragile X and Autism
SHERMAN BIOTECH
• Drug Development for Anxiety in Fragile X and Autism
SHERMAN BIOTECH
• Drug Development for Anxiety in Fragile X and Autism
– Lead drug SB15
SHERMAN BIOTECH
Fragile X (FXS)
Behavioral disorder, varying degrees of severity
Autism (ASD)
Behavioral disorder, varying degrees of severity
Genetic (X chromosome)
Genetic (multiple chromosomes)
~1 in 2000
~1 in 200
Abnormal motor, sensory and communication
Abnormal motor, sensory and communication
Anxiety
Anxiety
Autistic-like behaviors
Other autistic behaviors
“Most common known cause of autism”
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Anxiety in Fragile X and Autism
Significantly interferes with social development and learning
Controlling anxiety can greatly improve therapies
Current anti-anxiety drugs are broad acting and usually ineffective
Valium, Prozac, amphetamines, anti-psychotics etc
“Hit or Miss”, singly or in combination
Targeted drugs are needed
SB15 - a targeted “Glutamate Blocker”
Glutamate
hippocampus
Anxiety areas in the brain
Small Molecule
Cell-Cell Signaler
Glutamate
Small Molecule
Cell-Cell Signaler
ANXIETY
DECREASED
hippocampus
Anxiety areas in the brain
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Summary
Glutamate transmits signals between nerve cells
Glutamate is in parts of the brain that have a role in anxiety
Uncontrolled Glutamate stimulation is associated with anxiety
SB15 blocks Glutamate and decreases anxiety
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SB15 Summary to date
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Inhibits anxiety in animals and humans
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Mechanism of action is targeted and different
from antidepressants, amphetamines antipsychotics etc
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Non-sedative, non-muscle relaxant, non addictive and
no interaction with alcohol
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Easily synthesized ($ 0.1- 0.3 / dose)
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SB15 Challenges
Short life in blood, variation in patients
Solutions Exist
Controlled / Prolonged release capsules
Targeted release to brain
Skin patch development to prolong release
Drug stabilization
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The Drug Development Process
TASK
STATUS
Drug Discovery
Completed
Optimize Delivery
In Progress
Animal Studies
6 - 9 Months
Human Studies
2 Months*
* Clinic identified
Patients recruited
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Sales Projections*
Fragile X
Autism
100,000 diagnosed
1,200,000 diagnosed
50% will take drug
Off-label usage ?%
$20 / day
$20 / day
50,000 x $20 x 365 = $365 M / yr.
600,000 x $20 x 365 = $4,380 B/yr
Sherman Biotech will licenses the drug to a large pharmaceutical
company for a percentage of gross sales. 10-15%
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Experienced Resources:
Albert Einstein Medical School, Columbia University
Scynexsis Contract Research Laboratory
Fragile X Clinic, Rush Medical School
Fragile X Foundation
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Drug Development for Anxiety in Fragile X and Autism
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Diagnostic Test Development for Fragile X and Autism
– Hospital Laboratory
– Point Of Care
– Over The Counter
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The Need for a Screening Test for Fragile X and Autism
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Diagnosis is based on complicated behavioral evaluation
May be delayed 2-3 years after birth
Can be confused with other disorders, e.g., ADD, ADDH etc
Genetic test for fragile X is expensive, restricted and under-utilized
Most families want to know*
* Various studies
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Latest Research May Provide a Test
Glutamate: Chemical Signaler
hippocampus
Anxiety areas in the brain
Glutamate
Glutamate
receptor
Signal
enzymes
Diagnostic
Test
FXMP
Protein
Normal
IMPROVEMNET
Fragile X
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Diagnostic Development Process
TASK
STATUS
Test Discovery
Completed
Laboratory Version
In Progress
POC Version
6 - 9 Months*
OTC Version
6 Months**
* Pan Probe Inc
** Overlapping
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Drug and Diagnostic Development Expertise
David Schwartz, PhD, Chief Science Officer
Drug and Diagnostic Test Development Experience
Sam Hopkins, PhD, Advisor
Drug Development Experience (FDA Pre-Clinical)
Clive Taylor, MD, PhD, Advisor
Chairman, Department of Pathology, USC Medical School
SHUIJE CIU, MD,PhD
President, Pan Probe Inc
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Clinical Trial Expertise
Elizabeth Berry-Kravis, MD, PhD
Founder, Fragile X Clinic, Rush Medical Center
Sue Ellen Krause, PhD
Consultant, Fragile X Clinic, Rush Medical Center
Sam Hopkins, PhD, Advisor
Drug Development Experience (FDA Phase 1-3)