NeuroNascent, Inc.

Neuron Regenerative Therapies for Neurological Disorders


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Finding a drug that can reverse the devastating progression of neurodegenerative disease is the ultimate pharmaceutical moonshot. Neuronascent is answering the call.

Neuronascent, Inc. (NNI)
 is a development-stage biopharmaceutical company dedicated to developing disease-modifying therapeutics for some of the most difficult-to-treat brain disorders. Our flagship product, NNI-362, is a first-in-class therapy for Alzheimer’s disease and other neurodegenerative disorders that has been shown to reverse disease progression by stimulating the growth of new neurons in the brain.

Neurodegenerative disease is one of the most significant challenges in the healthcare space.

Neurodegenerative diseases, such as Alzheimer’s and Parkinson’s, work by destroying neurons in the brain -- the nerve cells that are the basic building blocks of our nervous system. Over time, this destruction wreaks havoc on the patient’s cognitive function and motor skills, destroying their ability to remember, walk, talk and, eventually, even swallow and breathe.  

For decades, the effects of these devastating diseases have been thought to be irreversible. The therapies available today focus on neuroprotection, or prevention of further decay of brain neurons.

But neuroprotective drugs can never halt or reverse a chronic neurodegenerative disorder. By the time chronic neurodegenerative disease is detected, there is already devastating neuron loss that cannot be restored by a neuroprotective drug.

NNI-362 is the first therapy that aims to go beyond neuroprotection to actually reverse the effects of Alzheimer’s disease and other neurodegenerative diseases.

Using the brain’s own compensatory regeneration mechanism, NNI-362 increases the number of mature neurons formed, replacing the neurons lost due to aging and chronic neurodegenerative diseases.

In an animal model of aging and neurodegenerative diseases, this “neuron regeneration” has been proven to elicit a reversal in cognitive deficits back to young or normal levels. 

Beyond a novel MOA (mechanism of action), NNI-362 has a number of other features that make it a highly promising therapeutic candidate: 

The GLP safety testing of NNI-362 was completed with the support of the
National Institute of Aging (NIA) pre-IND meeting with the FDA.

NIA provides this service for only a few therapeutics that they believe should move into human clinical trials for Alzheimer's disease -- a powerful vote of confidence in the potential of NNI-362 to meaningfully impact this disease. 

Other partners who have played an important role in the development of NNI-362 and Neuronascent’s novel pipeline include:  

Press Releases

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Press Release European Patents Issued.pdf

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Press Release NNI Third US Patent Issued.pdf

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Press Release NNI Appoints New Board Member.pdf

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Press Release NNI Secures Financing.pdf

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Neuronascent has already made significant progress in preparing NNI-362 for the market: 

  • GLP safety testing of NNI-362 complete.
  • Pre-IND meeting held with the FDA to gauge the tests needed for the IND application.
  • GMP manufacturing of NNI-362 complete (to be used in human clinical trials).
  • Patents for NNI-362 secured in the United States, North America, Europe, Asia and Australia (more information about NNI’s intellectual property position available upon request). 

With the pre-clinical steps complete, NNI is now preparing to enter the clinical phase of development for NNI-362. 

 

NNI-362 is just the beginning of NNI’s commitment to developing therapies that combat the most devastating brain diseases.

We have a robust drug development pipeline that features candidates that span a wide range of therapeutic possibilities, including these indications: 

To learn more about NNI, including development of NNI-362
and our other pipeline candidates, please request access
to the Business Plan tab of this profile.

Judith Kelleher-Andersson, Ph.D.
Founder, President and Chief Executive Officer (CEO)

She has over 20 years of experience discovering and developing therapies for central nervous system disorders. Prior to founding Neuronascent, she served as Director of Drug Development and Research at a number of leading organizations, including Neuralstem, Inc., Centaur Pharmaceuticals, and Senior Scientist at Cortex Pharmaceuticals, Inc.

While at Centaur, she headed the Alzheimer’s disease program in collaboration with AstraZeneca, and successfully brought a small-molecule agent to pre-nomination status as the primary inventor. At Neuralstem, she invented a neurogenic depression therapeutic that has completed Phase IIb human clinical testing.

Dr. Kelleher-Andersson has over 70 US, European, and global patents. She received her Ph.D. in biochemistry from University of Missouri-Columbia and completed postgraduate work at UCLA and in the Neurology Department at University of California-San Francisco.

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