The technology that guides our method of developing new neurotrophic molecules is based on the predictive computational analysis of the structural characteristics of the proteins of interest, for use as a medicament in the therapeutic treatment of neurodegenerative and / or inflammatory diseases.

Patent status

SUBMITTED

Priority Number

102018000003279

Priority Date

05/03/2018

License

INTERNATIONAL

Market

The current size and outlook of the markets for drugs for the treatment of neurological diseases (such as Alzheimer's disease) and the outcomes of brain trauma are worth hundreds of billions of dollars globally. However, these revenues are not generated by therapies aimed at promoting regeneration and restoration of the functions of the nervous system. The development of this type of therapies therefore represents an essential social need to which ProNeuro can respond by developing drugs that promote the protection and regeneration of the damaged nervous system.

Problem

It is impossible to repair the damaged brain

Despite an obvious need, there are no pharmacological treatment options for neurological diseases and neurotraumas because translation of neuroprotection from preclinical studies to clinical practice has so far failed.

Current Technology Limitations

Nerve growth factor (NGF), intranasally delivered to the brain, has been recently proven as a tremendously effective neuroprotective and neuro-reparative drug in 2 separate compassionate studies on pediatric Traumatic Brain Injury (Chiaretti et al, 2017).

PROBLEM: NGF Pharmacokinetics and Pharmacodinamics

NGF is highly vulnerable to the action of tissue proteases (fast clearance)
NGF-treated patients may suffer for dangerous side-effects

SOLUTION: Develop safer and protease-resistant NGF-like molecules.

Killer Application

The potential business linked to the patents and technologies used, involves the marketing of:

Outlicensing of patents and lump-sum payments upon achievement of milestones in the pharmaceutical pipeline.
Algorithms for the design of neurotrophins.
Eukaryotic expression systems for technology transfer.
PD / PK predictive models for neuropharmaceuticals.
Pre-clinical validation reports.

Our Technology and solutions

The technology that guides our method of development of new neurotrophic molecules is based on the predictive computational analysis of the structural characteristics of the proteins of interest, which leads to the modification of the native coding sequences with the aim of obtaining, through the construction of recombinant eukaryotics expression systems, mutated proteins that are safe, robust and easily producible both on a laboratory and industrial scale. We are also able to implement PD / PK prediction algorithms and to conduct "wet" pharmacological validations on preclinical models.

Advantages

The first mutated neurotrophic factor we developed is ProNGF-A / A73Y. It is a mutated variant of a poorly studied precursor form of NGF which, compared to the latter, may be more fitted for a potential use in the pharmacological treatment of neurological diseases. These advantages are:

Possibility of the molecule to be modified through genetic editing, to optimize both its pharmacology and production protocols.
Neurotrophic activity comparable to that of NGF
Greater resistance to cell and tissue proteases, which improve clearance parameters.
More advantageous pharmacological safety profile than NGF.

Roadmap

2017 - Clinical trials
2018 - Patent proNGF-A (usage)
2019 - Patent proNGF-A mut (production)
2021 - Spin-off CNR, Market Networking
Mid 2021 - Patent Patent proNGF-B mut
Subsequently Go to Market

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The team

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