Alzheimer's Disease (AD)

Disease Background
Alzheimer’s disease is the most common form of dementia, which progressively worsens with age. Though individuals can live with the disease for up to 20 years, it is now thought to be the 3rd leading cause of death in the US. Presently, 5.4 million Americans suffer from Alzheimer’s disease and that number may top 13.2 million by 2050. This devastating disorder may begin as a mild form causing new memory loss, but progresses to the point that the patient needs help with basic daily functions. Though caregivers provide 17 billion unpaid hours, eventually, in the later stages, patients are often placed in facilities that can provide the 24 hour a day assistance. This cost to society is in the range of 183 billion dollars annually. Unfortunately, there are no cures for the disease and the present marketed AD therapies, moderately reduce the symptoms of the disease, without reversing or improving the cognitive deficit for any sustained period of time.

NNI-362 Overview
Neuronascent has discovered a novel class of therapeutics, called Neuro-Restorative Agents, with the aim of reversing the cognitive deficit in AD patients by stimulating new neurons and protecting these “nascent” neurons from further neurodegeneration.

Through painstaking optimization a lead candidate emerged, NNI-362, that has now passed a pre-IND meeting with the FDA, and continues to be supported by the National Institute on Aging for the pre-IND safety testing. Strikingly, in vivo testing of Neuronascent's patented, orally-active therapeutic, NNI-362 significantly increased the number of neurons in a key memory region of the brain, which was associated with the actual reversal of memory impairment in elderly mice. In other words, aged mice receiving daily NNI-362 oral administration were no different than young animals in formation of healthy new neurons and in their cognitive behavior. A similar reversal of both cognitive impairment and neuron formation in the brain, back to wild type/normal animal levels was observed using a benchmark Down syndrome transgenic mouse model.

These brain-changing events, initiated by NNI-362 administration should provide more than just symptomatic relief to patients already suffering cognitive deficits in AD. With its extremely clean safety profile to date and a clear path forward, Neuronascent aims to raise the funds and/or support necessary for first-in-human trials of this potentially first disease-modifying therapeutic for mild to moderate Alzheimer’s patients.

Figures A & B
Greater Numbers of New Neurons in the Hippocampus of Down syndrome Mice Survive to Maturity and Functionality Following NNI-362 Administration (arrows point to new cells in neuron-functioning region)

A Down syndrome mice administered vehicle only       B Down syndrome mice administered NNI-362

For more information on Alzheimer's disease, please visit the National Institute of Aging’s website at www.nia.nih.gov/alzheimers.

 


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