# Neuron regenerative therapeutic, NNI-362, for first-in-human safety and PK for AD

> **NIH NIH R01** · NEURONASCENT, INC. · 2021 · $246,631

## Abstract

Project Summary / Abstract
There is only temporary, symptomatic relief for the approximately 5.3 million Americans thought
to already suffer from Alzheimer's disease (AD). With a decade of failures for neuroprotective
agents, Neuronascent discovered and developed a therapy that would not just stop further neuron
loss and dysfunction, but that would promote new neurons that survive to maturation, replacing
those lost. This neuron regenerative agent (NNI-362) should then halt or even reverse the
memory impairment in Alzheimer's patients. Neuronascent aims to submit an IND to the FDA for
NNI-362 for Alzheimer's disease, following completion of the IND application. The NIA supported
the FDA-required GLP safety studies showing the agent to also be safe, following a pre-IND
meeting with the FDA. Neuronascent, under this granting program, will enlist the help of regulatory
contractors to submit an IND application that includes a Clinical plan that assesses this NCE for
its safety in a healthy aged population. On obtaining FDA approval to initiate the first-in-human
testing of NNI-362 for Alzheimer's disease, Neuronascent aims to determine the safety, tolerability
and PK in healthy volunteers aged 50-72. Male and female volunteers will be administered a
single dose of NNI-362 orally at one of three ascending doses (SAD) , with and without food. This
will be followed by a 14-day daily ascending dose (MAD) test. Plasma levels of NNI-362 will be
assessed to determine pharmacokinetics and whether a potential efficacious dose has been
reached. If NNI-362 is deemed safe and well-tolerated, the agent could then be tested for ability
to promote new neurons in the hippocampus (vMRI) and halt or reverse dementia and impaired
function in Alzheimer's patients, in expanded safety and efficacy trials. Neuronascent's novel
neuron regenerative therapeutic targets aging, which is the greatest risk-factor for Alzheimer's,
and hippocampal neurodegeneration causing volume loss, that is directly correlated with
dementia in Alzheimer's disease.
[Unchanged from original R01 grant application.]

## Key facts

- **NIH application ID:** 10349352
- **Project number:** 3R01AG056561-02S2
- **Recipient organization:** NEURONASCENT, INC.
- **Principal Investigator:** JUDITH A KELLEHER-ANDERSSON
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $246,631
- **Award type:** 3
- **Project period:** 2018-09-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10349352

## Citation

> US National Institutes of Health, RePORTER application 10349352, Neuron regenerative therapeutic, NNI-362, for first-in-human safety and PK for AD (3R01AG056561-02S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10349352. Licensed CC0.

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