Myelin nano-vesicles for the treatment of neuropathies and neuro-inflammatory pathologies

Recently, nanoparticles and nanovesicles have been investigated as potential approaches for the treatment of neurodegenerative diseases. In particular, in the Biotech sector an increasingly deeper penetration of new treatment models and biological drugs based on cellular, subcellular and vesicle therapies is expected. The patent is based on the production of Myelin-based nanoVesicles (MyVes) produced by microfluidics, starting from myelin extracted from brain tissue. These vesicles find two major fields of applications as potential drugs or as supplements/nutraceuticals.

1. MyVes: drug for the treatment of neurodegenerative diseases with a strong inflammatory component such as Multiple Sclerosis, Alzheimer's, Parkinson's etc.

MyVes, produced with innovative protocols from myelin extracted from brain tissue, have been characterized in terms of physical and biological properties. Through in vitro, in vivo and ex-vivo experiments we have demonstrated that MyVes:

• They are approximately 100 nm in size, negative zeta potential, contain the main proteins and lipids of the myelin sheath and are biocompatible.
• They are able to reach the Central Nervous System (CNS) via nasal administration.
• They have a specific target by targeting microglia (CNS immune cells involved in all neuroinflammatory pathologies) inducing an anti-inflammatory phenotype.
• They can be loaded with drugs or molecules with therapeutic activity and then used as a brain drug delivery system, enhancing the effects of the drug. In fact, allowing the drug to:
  • reach the brain, reducing its distribution in non-target organs
  • act on brain target cells (microglia)
  • increase its half-life and stability
  • reduce the administration dose and therefore the adverse effects
• Moreover, as they are made up of myelin, they induce an antigen-specific immunotolerance effect (immunosuppression) in the peripheral immune cells of subjects with multiple sclerosis.

To date, the use of nanocarriers/drugs produced from myelin are not yet present in the medical landscape. Myelinated nanovesicles could be administered into the body and, through different approaches, counteract neuro-inflammatory diseases.

2. Nutraceutical application

In recent years the advent of nutraceuticals has revolutionized the treatment of CNS pathologies.  Nutraceuticals treatment, in fact, has numerous advantages compared to synthetic drugs. The reduced dose of the active ingredient, the absence of adverse reactions and the multiple biological function make the natural molecules excellent adjuvants of pathologies.

The inflammation of the CNS and the alteration/destruction of the myelin sheath that covers the neurons are the main causes of neurodegeneration in most brain diseases, such as Alzheimer's, Parkinson's and Multiple Sclerosis which represent the major cause of neurological disorders that afflict the world population.

Therefore, developing nutraceuticals capable of having multilevel action represents one of the major challenges for the treatment of neurodegeneration in brain pathologies. Myelin nanovesicles, acting both as anti-inflammatories and as myelin restorative, could support classical therapies for the treatment of CNS disorders. The simplicity of formulation of these nano-vesicles makes them suitable for oral suspension as they are easily dispersed in aqueous solutions.

The basic concept is to integrate myelin where there is a pathology with loss or alteration of the myelin itself and modulate the inflammatory process.

A supplement made of the same material subject to alteration and destruction in a pathology would have a significant impact on the buyer affected by the pathology and a significant impact on the market.