Prevacus Partnership

In June, 2019 Prevacus, Inc. and Odyssey Group International, Inc. entered into a Master Agreement to form a joint venture to develop a proprietary neurosteroid for treating pediatric Niemann Pick Type C Disease.

As part of the Master Agreement, Odyssey entered a share exchange agreement whereby each company has the right to purchase a minority stake in the other.
Odyssey plans to enter a JV agreement, 50/50 ownership, to develop a neurosteroid (PRV-001) for various brain maladies (leutodystrophies). Initial focus is on a disease called Nieman Picks Type C, a rare brain disorder in children that is always fatal. The joint venture has not yet been formed, but the company still expects to form the joint venture with Prevacus.
This is considered an “orphan indication” by the FDA and therefore has special considerations for the FDA approval process.

Prevacus, Inc.

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Prevacus and Odyssey

Joint Venture

  • A clinical stage company developing therapeutic agents for neurological disorders including Traumatic Brain Injury (concussion) and Niemann Pick Disease Type-C
  • Lead molecules PRV-001 and PRV-002 are proprietary neurosteroids with proven in vivo and in vitro efficacy in animal models of neuronal damage and safety studies in rat and dog
  • 5 other novel analogs are available
  • Intranasal delivery of PRV-001 and PRV-002 allows rapid targeted delivery to the brain
  • Prevacus Inc. and Odyssey International, Inc. intend to form a joint venture to develop the first drug to improve quality of life for Niemann Pick Type-C disease
  • Our primary focus is to improve the function and life span of infants and children who genetically develop Niemann Pick Type-C Disease
  • Both companies own 50%
  • Prevacus leadership is tasked with preclinical and clinical safety and efficacy data acquisition
  • Odyssey International leadership is tasked with funding and business development

Niemann Pick Type-C Disease

  • Niemann-Pick Type C disease (NPC) is an autosomal recessive, lysosomal storage disorder characterized by accumulation of cholesterol and gangliosides in the brain and liver
  • NPC is a rare (estimated US prevalence of 1:150,000) neurodegenerative disorder. Prevalence is 5X higher with Arabian decent
  • Children with NPC demonstrate neurological dysfunction with cerebellar ataxia, dysarthria, seizures, visual palsy, motor impairment, dysphagia, psychotic episodes, and progressive dementia
  • There is no effective treatment for NPC and it is a lethal disorder

PRV-001 MECHANISM

PRV-001 TOXICOLOGY

  • PRV-001 binds to the Pregnane X Receptor (PXR)
    • The PXR is an intracellular receptor found in neurons, glia and the endothelium of the blood brain-barrier
    • Binding of PRV-001 to the PXR activates multiple gene response elements promoting transcription of anti-inflammatories (CD55), anti-oxidants (gluthione s-transferase) and efflux channels (P-Glycoprotein) for toxins and fluid.
    • Further PRV-001 promotes neuronal growth and differentiation
  • PRV-001 is not a GABAergic compound, no fatigue
  • Acute and sub-acute dose ranging studies were executed in rats and dogs – SC, IN, IV routes
    • MTD (IV) = 38 mg/kg
    • Signs of toxicity were limited to vehicle
  • 14-Day GLP toxicology in rats and dogs
    • Rat: MTD = 46 mg/kg
    • Dog: MTD = 46 mg/kg
    • No drug-related effects noted in hematology, blood chemistry, BW, FC, or histopathology (except for slight nasal turbinate irritation)

PRV-001 SUMMARY

PRV-001 – a First-in-Class Neurosteroid for the treatment of Niemann Pick Type-C Disease
  • IP covers methods of preparation and methods of use
  • Few competing products currently in human trials
  • Pre-clinical efficacy underway
  • No drug-related toxicity observed
  • Nasal formulation finalization in progress