🔬TODAY’S BREAKTHROUGH
A placebo-controlled Phase 1a clinical trial for a novel compound, NNI-362, has yielded highly significant results. The therapy, designed to stimulate neuron regeneration, was safe, well tolerated in older, healthy adults, and achieved a marked reduction in a critical Alzheimer's disease (AD) biomarker.
The Discovery:
Oral administration of NNI-362 in healthy, cognitively-unimpaired older individuals (ages 50–72) achieved a nominal significant reduction in plasma phosphorylated tau181 (p-tau181) levels. At the two highest multiple doses, the drug significantly reduced plasma p-tau181 compared to pretreatment levels, while no change was seen in the placebo groups.
The Science:
NNI-362 is a novel small molecule designed to halt or reverse chronic age-related neurodegenerative disorders by promoting neuron generation.
The compound works through a unique mechanism of action, allosterically modulating a central kinase hub, S6 kinase, to activate translation and neuroprotection in the central nervous system.
The reduction in plasma p-tau181, a key biomarker associated with AD severity and progressive cognitive deficits, suggests that NNI-362 may modify disease pathology in the brain.
The drug was safe and well tolerated up to the highest dose tested (240 mg daily), with no serious adverse events or discontinuations reported in any cohort.
Your Action:
The results warrant future Phase 2 studies in Alzheimer's disease and age-related degenerative disorders.
For now, supporting your brain health is critical. Lifestyle choices like exercise promote neuronal progenitor proliferation and remain a key defense against chronic neurodegenerative disorders.
Bottom Line:
NNI-362 is a promising new neuron regenerative therapy that successfully reduced a core Alzheimer's biomarker in its first human trial.
Source:
First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population, Alzheimer's Research & Therapy, Judith Kelleher-Andersson, et al. https://doi.org/10.1186/s13195-025-01837-0
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Disclaimer:
This newsletter is for informational purposes only and does not substitute professional medical advice. Always consult with a healthcare provider before making any changes to your health regimen.