CLARKSVILLE, Md., Sept. 19, 2018 (GLOBE NEWSWIRE) -- Neuronascent Inc., a privately-held neuron regeneration therapeutics company, today announced that the National Institute on Aging (NIA), part of the National Institutes of Health, has awarded the company an 18-month R01 award. The grant award is expected to total just over $2.25 million and will fund the further development, including Phase 1 clinical trial of Neuronascent’s lead small molecule therapeutic NNI-362, an oral drug for mild to moderate Alzheimer’s disease (AD).



The new award continues earlier NIA support of NNI-362 development, where previous funding supported IND-enabling safety testing. The present award provides support for the completion of the IND submission to the FDA, and a first-in-human Phase 1 safety and tolerability clinical trial in healthy aged volunteers. “Neuronascent appreciates the invaluable support from the NIA for the continued development of our lead therapy aimed at reversing age-related disorders, specifically Alzheimer’s disease,” said founder and CEO, Judith Kelleher-Andersson, Ph.D. “This award, following a rigorous R01 academician peer-review process, provides compelling validation of our first-in-category therapeutic program, with the potential to improve the lives of so many patients with this mind-robbing disorder.”

Alzheimer’s is a disease of aging (the greatest risk-factor) but there is no therapy available to halt or reverse this chronic neurodegenerative disorder. The need is great to find a disease-modifying treatment for the 5.3 million patients, in the US alone, already suffering from this disorder. Recent NIA funding emphasis is allowing for the expansion of targets and innovative AD therapeutic programs, such as Neuronascent’s oral neuron regenerative therapy. With unknown etiology, AD has shown resistance to treatment, while a regenerative therapy, such as NNI-362, does not require full understanding of the cause(s) of AD.

R. Scott Turner, MD, PhD, Director of the Memory Disorders Program at Georgetown University, who will serve as Clinical Investigator on the project, stated, "NNI-362 is truly unique in aiming to halt or even reverse deficits in individuals with dementia due to Alzheimer's disease. Because many trials are focused on prevention in very early disease states, few studies are addressing the millions already suffering from this devastating disorder."

Howard Federoff, M.D. Ph.D., a Professor in the Department of Neurology at University of California-Irvine, commented, "Moving beyond targeting beta-amyloid, which has failed multiple times in the clinic, Neuronascent’s novel neuron regenerative therapy addresses another key problem of Alzheimer’s disease – the loss of functioning neurons. Neuronascent’s lead drug, NNI-362, is intended to reverse age-related neuron loss and restore cognitive function in Alzheimer's disease patients.”

About NNI-362

NNI-362 is Neuronascent’s lead patented oral therapeutic aimed at reversing age-related disorders by producing new neurons to replace those lost in chronic neurodegenerative disorders and aging. NNI-362 has a unique mechanism of action (MOA) that provides safety and selectivity for neuron regeneration, and was discovered through Neuronascent’s proprietary phenotypic screening program. This MOA takes advantage of neuron progenitors already in the aged brain, to form new neurons and protect them from degeneration in chronic diseases of the aged such as Alzheimer’s disease. This neuron regeneration process mimics what occurs in the young brain, and markedly enhances a natural (but usually insufficient) compensatory brain mechanism that generates new neurons from endogenous neuronal progenitor cells when age-related neuron degeneration occurs. Thus, NNI-362 is aimed at reversing age-related neuron loss and restoring cognitive function in Alzheimer's disease patients, and should also be useful for other disorders of the elderly, including Parkinson's disease and age-related hearing loss.

About Neuronascent, Inc.

Neuronascent was founded to discover and develop novel therapies to halt and/or reverse diseases of the central nervous system, an area with vast unmet needs. Through its proprietary phenotypic screening platform, Neuronascent has discovered a pipeline of now optimized small molecule oral lead candidates that are patented for Composition and Use.

Please Contact jkelleher@neuronascent.com or investrelate@neuronascent.com

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