Alzheimer's Disease

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 6th 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 of 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 24 hour a day assistance. This cost to society is in the range of 183 billion dollars annually.

Please view the Alzheimer’s Association’s 2016 Facts and Figures about Alzheimer’s disease video using the following link: https://youtu.be/ROTZxvil66A.

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.

Overview of Neuronascent’s Alzheimer’s Disease Therapeutic

Neuronascent has discovered a novel class of therapeutics, called Neuron Regenerative therapies, that aim to reverse the cognitive deficit in AD patients, by stimulating new neurons and protecting these “nascent” neurons from further neurodegeneration.

Through painstaking optimization of our patented family of Neuron Regenerative synthetic agents, a lead candidate emerged, NNI-362. This candidate has now passed a pre-IND meeting with the FDA, and was found safe through IND-enabling safety testing all supported by the National Institute on Aging.

In vivo testing of Neuronascent's patented, orally-active therapeutic demonstrated that 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 oral administration of NNI-362 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 or normal animal levels was observed using a well established Down syndrome transgenic mouse model.

These brain-changing events, initiated by NNI-362’s first-in-class mechanism of action should provide more than just symptomatic relief to patients already suffering cognitive deficits of AD. With NNI-362’s clean safety profile to date and a clear path forward, Neuronascent aims to gain the support necessary to run the first-in-human safety trials, of this potentially disease-modifying therapeutic for mild to moderate Alzheimer’s patients. While a number of pharmaceutical companies look at earlier and earlier stages of the disease, Neuronascent sees NNI-362 as potentially helping the millions of patients already suffering this debilitating memory and functional loss.

Greater Numbers of New Neurons in the Hippocampus of Down syndrome Mice survive to Maturit and Functionality Following NNI-362 Administration (arrows point to new cells in neuron-functioning region)

A Down syndrome mice administered vehicle (no therapy added)       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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