Neuronascent to Present Further NNI-362 Phase1a Data at CTAD 2022 for Alzheimer’s Disease
ROCKVILLE, Md., Nov. 08, 2022 (GLOBE NEWSWIRE) — Neuronascent Inc., today announced its abstract entitled “Reduction of plasma p-Tau181 from a Phase 1a Randomized Trial of NNI-362 in a healthy aged population consistent with amelioration of tau hyperphosphorylation in human differentiated neuron cultures” has been accepted for a poster presentation at 15th Clinical Trials on Alzheimer’s Disease (CTAD 2022) to be held in San Francisco, Calif., on Nov. 29 through Dec. 2, 2022. The primary goal of this trial was to assess the safety and tolerability of oral NNI-362 in healthy aged subjects.
“These findings are very encouraging since the pre-clinical results are indeed being mimicked in the clinic, including both safety and potential efficacy markers, as we move toward a Phase 2 proof-of-concept trial,” said founder and CEO Judith Kelleher-Andersson, PhD.
Dr. R. Scott Turner, MD, PhD, director of the Memory Disorders Program, Georgetown University, will be presenting this data at CTAD 2022 as one of the accepted late-breaking posters.
The Phase 1a single ascending and multiple ascending dose (SAD + MAD) trial of NNI-362 demonstrated a significant reduction from pretreatment-baseline of an Alzheimer’s disease progression biomarker, with no change observed with placebo in healthy aged subjects. This placebo-controlled, randomized trial was fully supported by a grant from the National Institute on Aging (NIA, part of the National Institutes of Health).
In topline results, NNI-362, administered from 10 to 240 milligrams orally, once daily, showed no serious adverse events and no dose-dependent adverse events.
Alzheimer’s is a disease of aging, the greatest risk-factor, but there is not a single therapy available to halt or reverse this chronic neurodegenerative disorder. Results in aged subjects demonstrated that on Day 16, with SAD/MAD daily oral dosing of placebo and NNI-362 at 120 mg and 240 mg, NNI-362 significantly reduced phosphoTau181 levels compared to baseline, while no reduction with placebo. PhosphoTau181 is a plasma measure of potential Alzheimer’s progression in brain.
NNI-362 targets adult-born neuron regeneration and neuroprotection through a unique mechanism to promote translation and neuron survival (Sumien et al., 2021: https://doi.org/10.1186/s13287-020-02126-3) in models of age-related disorders. This disease-agnostic neuron replacement / enhancement therapy aims to be a first-in-class oral therapy to halt and reverse Alzheimer’s and other age-related neurodegenerative disorders.
The research reported in this press release was supported by NIA under award number R01AG056561. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
In aging patients, endogenous neuron regeneration is diminished. This diminution is exacerbated in patients suffering from neurodegeneration (for example, Alzheimer’s patients). NNI-362, Neuronascent’s lead, patented, new chemical entity, was developed to reverse age-related disorders by producing new neurons to replace those lost due to chronic neurodegeneration. This ability supports the drug’s use to halt and reverse Alzheimer’s disease and other age-related neurodegenerative disorders.
About Neuronascent, Inc.
Neuronascent, Inc., [www.neuronascent.com] a privately-held, clinical-stage pharmaceutical company, was founded to discover and develop novel therapies that treat CNS disorders with high-unmet need by replacing and enhancing neuron numbers, not just neural connections. Through its proprietary phenotypic screening platform, Neuronascent has discovered a pipeline of small molecule regenerative candidates with patents issued, including NNI-351 for Fragile X syndrome, a rare pediatric disorder.
Safe Harbor Statement
This release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are commonly identified by words such as “would,” “may,” “will,” “expects,” and other terms with similar meaning. Forward-looking statements are based on current beliefs, assumptions and expectations and speak only as of the date of this release and involve risks and uncertainties that could cause actual results to differ materially from current expectations.
Judith Kelleher-Andersson, PhD.
Founder and CEO